First, the National Clearing House for Poison Center, a division of HEW, reports that most poisonings are in children under five. This in itself clearly proves that it is not the pesticide application but an accidental exposure that causes the harm. And pesticides, representing only 3.2% of the cases in 1975 were less frequent offenders than such material as soaps, plants, vitamins and minerals, aspirin, cold medicines and even perfumes.

Next, we carefully examined our Orkin pesticide-use records for 1975 and 1976. We made approximately 6,000,000 pestcide applications and these were administered by 3,400 of our technicians. Our personal injury claims due to pesticides for this two year period were 68 and our total cost of treatment for these was $4,410. There were no fatalities, of course, and none of our customers were injured. Compared to our revenue of $264,000,000, for this period this is an expense percent of 0.0017%. We are proud of this record and think it factually shows the safety with which pesticides are being used by our structural pest control industry.

Thus, nationally, pesticides occupy a very minor role in use and risk.

Specifically, we would like to recommend the following changes to FIFRA: 1. We do need some clarification on our structural pest control position under FIFRA and EPA. Our industry considers that under FIFRA, we are "Certified Applicators" to use or direct the use of restricted use pesticides. The Association of American Pesticide Control Officials supports our contention that we are

users.

The Agency, by some stretch of the interpretation calls us "distributors" and "sellers". We willingly take the responsibility of the function we perform but are most reluctant to bear additional responsibilities because of an Agency interpretation. We respectfully ask that this point be clarified so that we may efficiently go about our business as users of pesticides. 2. In addition, there must be some relief from the present rigid interpretation of "Use Inconsistent with the Labeling". We support the amendment wording advocated by EPA and emboding the following conditions:

1. Application at a dosage, concentration, or frequency less than that specified on the labeling;

2. Application against a target pest not specified on the labeling, provided that the application to the food, feed or fiber crop, animal or site is specified on the labeling;

3. Any method of application not prohibited by the labeling; or

4. Any mixture of a pesticide with a fertilizer not prohibited by the labeling.

We also support the recent changes in position that the Agency has adopted to expedite classification, to reduce efficacy demands, and to permit conditional registration.

There is a distinct inter-relationship between life, food, and pesticides. For life, there must be food, and for an abundant and economical food supply, we must have pesticides. Through pesticide use, agricultural and structural pest control join in bringing our country this abundant and economical food supply. Pesticides are an absolute necessity in this procedure. Biological control and integrated pest management are worthy in concept, but at this time neither nor both are a substitute for pesticides.

We count on this committee to provide changes and improvement in FIFRA. Until EPA's performance record in pesticide control improves, this committee must provide attention and direction. Only in the illumination of such hearings, does EPA seem to respond to logic from outside. Industry and environment must co-exist. Congress, apparently, must be the catalyst to assure that we do. So give us your periodic attention. Then, EPA, under Mr. Costle's leadership and with a full consideration of benefit-risks, can come back in step with agriculture and all others who want and demand safe pesticide use.

We thank you Mr. Chairman, Committee members, for letting us be here with you today.

STATEMENT OF EDGAR W. DUSKIN, EXECUTIVE VICE PRESIDENT, SOUTHERN AGRICULTURAL CHEMICALS ASSOCIATION

I am Edgar W. Duskin, Executive Vice President of the Southern Agricultural Chemicals Association. Our Association is an independent, voluntary, non-profit trade association. It represents over ninety percent of the companies which

formulate, distribute and manufacture agricultural pesticides in thirteen southern states.

We testified at the FIFRA Oversight Hearings held in March and April 1977. I have been advised by staff that the committee members have studied or heard previous statements and positions. Under this presumption, I will not repeat the detail of my previous statements but will confine my remarks to a re-statement of regulatory philosophy and FIFRA changes which we believe are essential to orderly and fair administration of the law. I request that copies of my previous statements before the Senate and House Committees and Sub-Committees be made a part of the record of this hearing. I will be happy to try to answer any questions you may have regarding our recommendations.

PHILOSOPHY OF PESTICIDE REGULATION

We believe there are two key elements of guidance affecting the administration of FIFRA which are missing. This lack has contributed to mismanagement of the pesticide regulatory program.

First: There is need for a simple, clear statement either in the law or in the hearing record which states the "Sense of the Congress regarding agricultural pesticides. It should be spelled out that they are to be treated as specialized, essential, useful tools of agricultural production and not looked upon as just other pollutants to the environment. The philosophy toward regulating them should be to insure their continued development and availability on the market for use under control rather than attempting to eliminate them with the slightest hint of potential danger.

Second, and related to implementation of this philosophy is that there is an urgent need for a National Cancer Assessment Policy which can be followed by all in the evaluation of the real carcinogenic potential and risk under controlled uses of a substance in question. An absolute standard such as the Delaney Clause in the Food and Drug Act is unrealistic as the "saccharin" example points out.

SPECIFIC RECOMMENDATIONS

1. Prohibit use of rebuttable presumption against regulation.-(Sections 3 and 6). These procedures are created only in regulations and they have no basis in the law. They have become a pre-cancellation period which has the effect of stymieing production and sale. Adequate cancellation procedures are already in the law. Their expansion by regulation should not be allowed. Section 6(b) (2) should have a sentence added which says, in effect that "the procedures established herein are sufficient for removal of unreasonably dangerous products from the market. Additional measures which have the effect of or lead directly to cancellation, such as "presumptions against registration are unnecessary and redundant."

2. Resolve trade secrets/compensation for data.-(Section 3 and 10). A compromise position which compensates the owner for data he has expended large sums to develop while not unreasonably limiting competition should be achievable.

3. Authorize efficacy data to be certified to for registration. We understand EPA supports this position.

4. Direct testing requirements at technical/active ingredients (Section 3).— We understand this procedure is recommended by both the White House and EPA. 5. Authorize granting of conditional/"me too" registrations (Section 3).—We understand EPA generally supports this position and is attempting to do part by regulation. The law should facilitate these type registrations for additional uses, extension to additional crops and additional labels for products already registered.

6. Civil penalties should be limited (Section 4).-Penalties for technical violation of the rules are out of proportion to the damage or even risk thereof caused by the violation. Section 14 should have a sentence added which says that, "penalties assessed will be scaled according to the degree of adverse effects the violation caused or risked to man or the environment. First and minor offenses which do not cause adverse effects should be treated as "de minimis."

7. Labelling should be a guide (Sections 3 and 12).-Many have recommended the addition of a definition of "use inconsistent with labelling." EPA appears willing to go along with this. We believe this approach, though minimally satisfactory, does not get to the heart of the problem. We prefer to see the law define "USE" in the simple and restrictive sense of "Application to achieve an intended

purpose" and "MISUSE" as an "Act involving a pesticide which causes unreasonable adverse effect on man or the environment." Adoption of these definitions of "USE" and "MISUSE" would allow section 12(a) (2) (g) to be worded simply that it is "unlawful to misuse a pesticide." "Labelling" then would become what it was originally intended to be, a guide to proper use.

8. Authority of States to register products for emergency uses, minor uses, and special local needs must be less restricted (Sections 18 and 24c).-Rules promulgated by EPA prevent state registration of competing products for the same use and require submission of full data. If 24c registrations are to be effective, the law should be changed to preclude such restrictions being imposed. We suggest addition of words to the effect that "the authority once granted to a state to issue registrations under this section, may not be abridged by regulations which tend to eliminate competitive use of several products available to meet the special local need. Data and tolerance requirements may be tailored by the Administrator to facilitate registration. Product liability for such registrations shall be limited to the state registrant." The waiver of data authorization would also facilitate minor use registrations. The necessity for authorizing EPA to establish temporary tolerances where required is essential.

9. Funding for public participation in proceedings under this act should be specifically prohibited. We strongly oppose proposals by EPA to provide government (taxpayers) monies to fund participation in regulatory and other proceedings by witnesses, etc., who have "small financial stake in the outcome." We seriously question the ability of any agency to fairly select recipients and believe that this will unnecessarily complicate and prolong the process of accomplishing the public's business. We urge specific prohibitions in Section 27 of the act to prevent such a waste of money and risk of further complicating the already burdensome regulatory process.

10. Close and continued oversight.-Despite the best intentions of all we believe regulations developed by EPA have been a major contributor to the registration impasse; therefore, we urge that Congress retain the right to review and approve not only the law but regulations having the force of law which are promulgated under its authority.

SUMMARY

In essence, we believe congressional intent should be stated to the effect that criteria should not be established which will tend to unreasonably restrict registration or competition among products. If EPA registers a formulation in compliance with standards established for one registrant, it should register the same formulation for all who apply as valid applicants, provided compensation for data nor trade secrets are not at issue. All criteria being the same, if registration for all applicants cannot be granted then none should be allowed. No registration should be denied unless it is clearly shown that the intended, proper use of the pesticide will seriously risk causing unreasonable adverse effects on man or the environment not controllable through restrictions on uses. If these principles are spelled out and followed, the law can be properly and fairly administered to the benefit of all.

STATEMENT OF F. FARRELL HIGBEE, EXECUTIVE DIRECTOR,
NATIONAL AGRICULTURAL AVIATION ASSOCIATION

Mr. Chairman, members of the committee, I am Farrell Higbee, Executive Director of the National Agricultural Aviation Association. Our association represents an industry that uses approximately 8000 aircraft, operated by 3300 companies, to apply 65% of the pesticides used on agricultural and forest lands, for insect vector control, seeding, and fertilization, in the United States. The industry has conducted its business under the same thrust as Amended FIFRA since 1966, when Federal Aviation Regulation Part 137 was adopted, which stated that we could not use a pesticide contrary to its Federally registered label.

Obviously, the administration and interpretation of Amended FIFRA has had a tremendous and sometimes insidious impact on agricultural production through actions taken in regard to ag aviation, particularly because of the strict interpretation of certain parts of Section 3 and of Section 12 (a), 2(G).

The administration and interpretation of amended FIFRA is causing a frustrating economic and psychological impact on production agriculture that is almost beyond definition and certainly most difficult to measure in economic terms. No

other class of chemicals has had as close scrutiny as pesticides. If they had, we certainly would not be using salt, pepper, coffee, alcohol, or eggs today.

The consideration and eventual enactment of Amended FIFRA by this committee and others took all of the historical data into consideration. The regulations that have since been written have largely been promulgated on probability, unfortunately based in part on pure conjecture, or baseless fear of risk and certainly dependent on extrapolation from questionably valid animal data to human exposure or risk. Therefore, the problem is not the force of the basic law, but the interpretation of that law through regulation or mechanism of regulation (i.e., the Rebuttable Presumption Against Registration process (RPAR)).

We have previously submitted some additional definitions and some specific recommendations to the House Agriculture Committee, but I have restated them here in order that they would become part of your record.

In view of the history since the enactment of Amended FIFRA, we felt it was essential to be here today to present some additional amendments that would prevent the proliferation of unreasonable regulations and perhaps restore some of the Congressional intent that was contained in the committee reports during the enactment of the law.

The following definitions need to be added to the law. They may not be entirely complete, but we asked many other agricultural groups, USDA, and EPA to review them and we all hope that in your ultimate wisdom you can formulate the most proper language needed to make crystal clear what we consider to be a good law.

(ee) Use. The term "use" means "application" when it is used in reference to a pesticide user, and the term "use" means "use pattern" when it is used in reference to registration and labeling.

(ff) Use Pattern.-The term "use pattern" refers to the label directions given by the registrant and includes site, amount of active ingredient or product per unit area and frequency of application but excludes application equipment sold separately.

(gg) Changed Use Pattern.—The term "changed use pattern” means any change in the way a pesticide is permitted to be used, including allowing a new use or restricting, conditioning, or prohibiting any previously registered, labeled or allowed pesticide use.

(hh) Use Inconsistent With Labeling.-The term "use in a manner inconsistent with its labeling" means (1) application to a crop, animal, or site not in the labeling claims: (2) use at an amount of active ingredient or product per unit area exceeding those in the labeling or (3) failure to follow restrictions or limitations on the labeling.

These definitions relating to "use" are necessary to set the stage for a proper interpretation of Congressional intent as evidenced by Paragraph Eleven of House Report 92-511, page 16 (1971), entitled "Inconsistent with label". It says:

It is the intent of this definition that articles designated for general or restricted use may be used by a pesticide applicator at a lower dilution than that specified on the label. While it would obviously be dangerous to permit more concentrated solutions to be used, the Committee recognizes the need to apply the standard of use "inconsistent" with respect to labeling in a common sense manner. Thus, for example, the use of pesticide solutions in lower amounts for aerial spraying, when otherwise determined to be safe, should be permitted. (Emphasis added.)

This recognizes the need for a user to vary dilution rates when that practice has otherwise been determined to be safe, through field testing or long standing practices. In our business this type of variation occurs thousands of times per day. One of the reasons is for energy conservation, in being able to haul less total solution to a target site and in many cases, avoid over-application of the active ingredient. The past practice of strict interpretation of Section 12 (a), 2 (G), has made this a technical violation of FIFRA.

(ii) Application. The term "application" refers to the act of an applicator in applying a pesticide.

(jj) Applicator.-The term "applicator" means the person who dilutes, combines, or mixes pesticides, but does not otherwise change the chemical properties of the compounds, for the purpose of application to the pest or site.

(kk) Custom Blender.-The term "custom blender" means the person who adds a registered pesticide to a fertilizer and the blend is prepared to order and not held in inventory.

These three definitions appear to be necessary because of the sometimes referred-to "Bonin Memorandum" of January 1976, which in the eyes of the En

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forcement Division made every applicator who sold pesticides as a part of his services subject to Sections 3, 7, and 9, of the law in terms of registering his mix of pesticide (s), registering his establishment, and submitting to involuntary inspections.

(11) Method of Application.-The term "method of application" refers to the manner by which the pesticide is delivered to the pest and/or the target site, such as foliar applied, soil injection, pour-on etc., but excludes equipment used for application when sold separately.

During the enactment of FIFRA the definition of "device" was carefully constructed by Congress to prevent the regulation and standardization of equipment by EPA. The fact is they have eroded this definition by considering equipment a part of the method of application.

In view of these and many other problems our association supports:

A change in the wording of Section 3 (c), (2) to limit the data in support of certain registration or re-registration in the case of specialty uses. (See attached.)

EPA's proposed amendments to Section 3 (c) to add a new sub-section (7) and Section 18. We also support their idea but not necessarily their language for a generic approach to registration.

A requirement by the Congress to rescind all of the Section 3 regulations and to re-write them with more attention to an economic/environmental balance and increased authority for state registration processes.

A requirement for EPA to review its personnel policy on the management and decision-making levels to inject more of a requirement for scientific expertise. A legislative proposal, using a federally funded approach, to set up a “bench mark" research program in cancer research that would eventually lead to a national cancer policy acceptable to all agencies. By setting up a "bench mark” of risk using all of the common things that humans use or are exposed to each day, such as caffeine, pepper, aspirin, etc., compared to those compounds that have known carcinogenic properties, we could establish a logical measure of risk for any chemical and thereby establish a logical "measure of use" or dose relationship concept without being subject to the present level of emotion that is being used to scare the public into hasty decisions.

A moratorium on the use of the Delaney Amendment to the Food and Drug Act until the above research program has indicated the need for action or has shown in the proper perspective all chemicals which are consumed by the public. Everyone agreed until now that Delaney did not apply to pesticides but two recent court decisions, i.e., the cancer principles stated in the Aldrin-Dieldrin case, and the "no threshold level" principle stated in the Heptachlor-chlordane decision, are believed by many to bring it into play.

The review of previous decisions of the EPA in cancellation of pesticides, particularly DDT, since the preponderance of evidence points to these as political decisions and not scientific decisions.

In summary, we feel that many of the regulations promulgated by EPA are unconstitutional, specifically Section 3 regulations. At first, all of these regulations were being considered by knowledgeable people, but since 1974, these duties were removed from them and they have since been exiled. The best public service this committee could perform would be to insist on a logical, knowledgeable approach to the law by the personnel of the agency!

SEC. 3(c) (2):

“(2) Data in support of registration.—The Administrator shall publish guidelines specifying the kinds of information which will be required to support the registration of a pesticide and shall revise such guidelines from time to time. If thereafter he requires any additional kind of information he shall permit sufficient time for applicants to obtain such additional information. The Administrator in establishing standards for data requirements for the registration of pesticides shall make such standards commensurate with the anticipated extent of use, pattern of use, and level and degree of potential exposure of man and the environment to the pesticide. In the development of these standards, the Administrator shall consider the economic factors of potential national volume of use, extent of distribution, and the impact of cost of meeting the requirements on the incentives for potential registrant (s) to undertake the development of the required data. Except as provided by subsection (c), (1) (D) of this section and Section 10, within 30 days after the Administrator registers a pesticide under this Act he shall make available to the public the data called for in the