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The cotton industry is gravely concerned about the availability of essential pesticides. Our important chemical "tools" continue to be removed from the market by cancellation and other restrictions while at the same time regulations are stymieing research and development of effective new pesticides. Unfortunately, due to the unavailability of hand labor and proven non-chemical pest controls, cotton farmers must continue to rely to a large extent on chemical control measures for both plant and animal pests.

We are especially concerned about the influence on pesticide policy of those who ignore experience and scientific evidence and, who have no appreciation for the necessity and benefits of pesticides.

Since FIRA was amended, EPA has taken very drastic and questionable actions, like cancellation of DDT, aldrin, and dieldrin, and presuming against re-registration in the RPAR process, without first determining whether or not the restricted use provisions of the Act applied to these products would satisfactorily protect the environment.

In the past, EPA has justified its actions by overstating environmental and health risks and understating the benefits and economic impact on farmers. We feel strongly that an agency other than EPA should assess the economic impact of such actions and suggest that this agency be the U.S. Department of Agriculture.

The cost for research, development, and registration for new chemicals is significantly increased by regulatory requirements. Producers of pesticides, because of possible loss of their new products through further regulatory actions, understandably price their products high at introduction in an effort to recoup research and development expenses in a short time. The end result of these factors is a serious economic impact on farmers and other users.

The requirement for re-registration of pesticides is an area of major concern to us. The regulations and proposed guidelines give little or no weight to long-time safe and effective use of a pesticide. We firmly believe that where no health or environmental problems have resulted from the use of a pesticide, the re-registration requirements should be minimal.

The primary mission EPA has in protecting the environment puts the Agency in the position of being an adversary to the registration of pesticides rather than an objective reviewer of costs and benefits. Over-regulation and over-reaction through excessive and unneeded controls and data requirements are major causes of EPA's current pesticide registration problems.

Patents on many of our important pesticides have expired or will be expiring within the next few years. Patent holders are reluctant to go to the expense of collecting additional data to support re-registration when they know their product will soon be nonpropietary. We're in favor of incentives for commercial research and development of pesticides, but we also favor continuation of competition among suppliers.

Registration of pesticides has been at almost a complete standstill for the past year. New pesticides are not being registered and EPA is making very little progress in re-registering pesticides.

Some of the changes in FIFRA now being recommended by EPA offer promise for improving the very critical registration and re-registration situation. We support EPA's efforts in this respect.

We are especially concerned about the RPAR process. Those pesticides which appear to EPA, based on data currently available, to cause unreasonable adverse effects on man or the environment must undergo a more detailed evaluation. In such cases, EPA presumes that the risks are too great for re-registration and it is up to the registrants and other interested parties to rebut such presumption by showing that the risks are not great and/or the benefits of use of such pesticides exceed the risks. Thus, "Rebuttable Presumption Against Registration", often referred to as RPAR, has become a key part of the review and registration process. The restricted classification approach in FIFRA as devised by Congress is, we feel, a more valid way than RPAR to deal with pesticides under question. While the registrant is allowed an opportunity to rebut his presumption, from past experience we believe that, despite evidence arguing against its position, EPA will not change its initial presumption. Once the RPAR tab has been attached to a pesticide, the stigma against it remains, even if the presumption should be cleared later.

Several pesticides, including two important cotton insecticides, have already been officially tagged as RPAR. As recently as May 25, Toxaphene, which is used extensively on cotton and many other crops, was put on RPAR status. It seems

unusual to us that along with the EPA's announcement of Toxaphene's RPAR, the Agency also announced availability of a 20-minute video-tape of its case against the chemical. It is our understanding that RPAR is supposed to be an extension of the prere-registration review process. Such a "Hollywood" approach hardly seems appropriate for an objective review process. It makes you wonder if EPA has already determined the results before the review.

The latest EPA list we have seen contains 58 pesticide groups that are candidates for RPAR status. The list contains a number of pesticides that are extremely important to cotton producers. Among these are DSMA, MSMA, EPN, Terraclor, Arsenic Acid, Cacodlylic Acid, Folex, Def, Sevin, Lorox, Paraquat, Lindane, and Cygon. Many more undoubtedly will be added.

Of special concern to our industry is the inclusion of five of the six cotton harvest-aid chemicals that are registered and used. It is our understanding that sodium chlorate, the remaining harvest-aid chemical, also is now under review as a possible RPAR candidate.

EPA is also failing in its attempt to minimize certain problems caused by label use restrictions. In May of 1975, the Agency instituted a series of Pesticide Enforcement Policy Statements (PEPS). Since the inception, seven PEPS have been published. Four of these PEPS 1, 4, 5, and 7 are of major interest to farmers.

With the exception of No. 4, these PEPS have in a great part been unworkable and have created considerable hardships on farmers. Further, in many respects, they go beyond the intent of Congress as expressed in the legislative history of FIFRA.

The last concern we wish to discuss is the greatest of them all. It is our concern about the principles of carcinogenicity that EPA uses for regulating pesticides.

The criteria being used do not reflect the main stream of scientific thinking on the subject. If such principles were valid and truly needed to protect humans from carcinogens, they would be equally valid and needed for protection against mutagens, neurotoxins, teratogens, and others. The truth is that application of these principles on such a broad scale will lead to the prohibition of all pesticides, all industrial chemicals, all pharmaceuticals, and numerous other substances including many foods. It will become a question of which comes first-starvation because essential agricultural chemicals are not available to produce food or starvation because the food substances themselves have been prohibited. Regardless of food, the human race would still be exposed, based on these principles, to so-called cancer-causing substances that exist naturally.

The Public Health Service, National Institutes of Health, U.S. Department of Health, Education, and Welfare has published as PHS Publication No. 149 several Surveys of Compounds Which Have Been Tested for Carcinogenic Activity. The first of these covered the literature through 1947. Several supplements have been published since then. These surveys show that many common chemicals that have been used for many years-aspirin for example have resulted in tumor formation in tests with laboratory animals. There is also scientific evidence of stress causing tumors in animals.

We believe that publicity and other statements from EPA leave the impression with the general public that the incidence of human cancer is rising when, in fact, with the exception of lung cancer, mortality rates of cancer are either static or decreasing.

We do not argue the fact that some pesticide chemicals have resulted in increased tumor formation in laboratory animals when fed high dosages for extended periods of time. We do contest the lack of true risk evaluation that EPA and other regulatory agencies place on results of such tests.

Another "principle" we believe to be unrealistic and without scientific basis is the concept that a threshold exposure level for a carcinogenic agent has no practical significance because no valid method of establishing such a level exists. Many authorities believe there is a finite dosage level for carcinogenic agents below which cancer or even tumor formation is not induced.

The fallacy of such cancer principles has received a lot of public attention in the last three months in regard to the proposed banning of saccharin by FDA. At this point, we want to emphasize that the cotton industry does not take lightly the lives of human beings. We, too, are concerned and interested in reducing and eliminating cancer among people of the world. However, we strongly feel that a more scientific and realistic approach in regard to the principles of

carcinogenicity used in regulatory decision-making is not inconsistent with such a goal.

We would like to submit the following suggestions for this Committee's consideration.

LABELING FEXIBILITY

FIFRA needs to be amended to provide more flexibility in pesticide labeling. EPA needs the authority and Congressional directive to enable labels to be updated with practical and generally accepted technology and use instructions without requiring registrants to undertake expensive time-consuming procedures in applying for label changes.

APPLICATIONS FOR REGISTRATION SPECIFIED TIME PERIOD FOR REVIEW AND ACTION

Whether the applications be for experimental registrations or full label clearances, EPA should be required to complete the reviews and act within a specific time frame by either registering the pesticide or notifying the applicant to the contrary. The reasons for denying the registration should be given to the applicant. It is suggested that this time frame be 90 days, with an additional 60 days extension if mutually agreed to by the applicant and the agency.

BENEFITS VERSUS RISKS

FIFRA should be amended to make it clear that Congress intended for the benefits of using pesticides to be truly assessed and weighed against the risks before EPA takes any precipitious action against their registration.

CLARIFICATION OF "UNREASONABLE ADVERSE EFFECTS"

FIFRA should be amended so that the meaning of "unreasonable adverse effects' is clarified. This clarification should encompass a risk assessment, taking into account the maximum level and route of exposure to man and the environment, persistence and fate of the pesticide in question under reasonable precautions prescribed for handling and use of the pesticide.

MORE FLEXIBILITY AND AUTHORITY FOR STATES

The present provisions under FIFRA and its regulations preclude state adaptation and judgment in registering pesticides for special local needs. This should be corrected through an amendment to FIFRA. Furthermore, consideration should be given to specifying that a certain amount of funds be made available to states for carrying out their responsibilities under the Act.

PESTICIDE ENFORCEMENT POLICY STATEMENTS (PEPS)

Recognizing how completely unworkable most of the PEPS are a new definition for, the term "use in a manner inconsistent with labeling" should be spelled out in the Act. We suggest that the definition recommended by the State-Federal FIFRA Implementation Advisory Committee and others be used. It reads as follows: "The term 'Use in a manner inconsistent with the labeling' means only: (1) application to a crop, animal, or site not in the labeling claims; (2) use at dosage or rates exceeding those in the labeling; (3) failure to follow restrictions or limitations on the labeling; (4) failure to follow labeling directions in the storage or disposal of pesticides."

REBUTTABLE PRESUMPTION AGAINST REGISTRATION

EPA should be directed to discontinue the Rebuttable Presumption Against Registration (RPAR) process or set requirements that are reasonable and realistic. These requirements should be developed jointly by a task group of EPA, USDA, states, pesticide manufacturers, environmental organizations, and user organizations. The requirements should include consideration of benefits versus risks, longtime safe use, and exposure/risk factors early in the review process and prior to any public release that tentatively or officially "labels" a pesticide as an RPAR compound.

SEPARATION OF REGISTRATION FUNCTION

Recognizing that EPA has been an adversary to the registration of pesticides and that it has failed to carry out this very important aspect or function of FIFRA as intended by Congress, we recommend that the pesticide registration function be transferred to USDA or another appropriate agency that will be responsive to the needs of agriculture and other groups which in turn extrapolate to the needs of consumers of food and fiber.

NATIONAL CANCER POLICY

We strongly urge that a realistic and scientifically acceptable cancer policy be established that will apply equally in determining actions by EPA, FDA, and other regulatory agencies. This policy should be developed by an appropriately constituted scientific body like the National Academy of Sciences that is outside the jurisdiction of regulatory groups such as EPA and FDA.

TRADE SECRETS

On Section 3(c) (1) (D), the need to resolve this is very urgent. It should be done in a positive way that will keep industry incentives high to continue research and development and will at the same time maintain vigorous competition among the firms producing agricultural chemicals.

Mr. Chairman, many of EPA's actions are dependent on the Administrator's discretion and in the past, farmers and other users have suffered unnecessarily from unwise use of this discretionary power. A new Administrator is now at the helm of EPA. We hope that more reason and wisdom will now be reflected in the decisions.

We see encouraging evidence that the new administrator is going to be more objective. We support his recommendations for conditional registration, separation of classification from registration, reduction of EPA review of efficacy data and the technical product approach to registration.

Thank you.

STATE OF VERMONT, DEPARTMENT OF AGRICULTURE, Montpelier, Vt., April 19, 1977.

Hon. PATRICK J. LEAHY,

1203 Dirksen Office Building, Washington, D.C.

DEAR MR. LEAHY: It is my understanding that the House Agricultural Committee recently held hearings on the proposed extension of the Federal Insecticide, Fungicide, Rodenticide Act (FIFRA) that is administered by the Environmental Protection Agency (EPA), Office of Pesticide Programs.

As a regulatory official, I am greatly concerned about the possibility of this legislation being extended for 18 or possibly 36 months in its present form. I feel that the Agency in its interpretation of the present law and in its regulatorymaking process has created many problems that are now unresolved simply because it has taken a hard-line attitude in interpreting the federal law instead of a more logical common approach. In not modifying the law now, Congress is merely prolonging a necessary assessment of unresolved issues which have brought the whole process to a halt.

Actually, I am convinced that many of the current problems with the law don't originate in the Office of Pesticide Programs but originate in the Office of General Counsel. Our problems lie in the manner in which the Office of General Counsel interprets the law, and it seems inconceivable to me that simple reorganizations and staff reshufflings that the Office of Pesticide Programs are currently going through will ever provide a solution. Listed below are some examples.

(1) The Office of General Counsel has declared that any applicator engaged in the business of applying pesicides is actually selling and distributing pesticides at the same time; and, therefore, the Agency is authorized by FIFRA Section 9(a) to conduct administrative inspections of establishments where pesticides are held for distribution or sale. I do not believe that a small pesticide control operator making a living applying pesticides should be considered selling or distributing pesticides. I feel that such an interpretation will hinder the application of pesticides in the future by reputable applicators. FIFRA

should be amended by defining pesticide producers and formulators as being in the business of selling and/or distributing pesticides thus resolving this problem.

(2) My second major area of concern deals with registration, reregistration. and the process of rebuttal presumption against registration (RPAR) as it affects pesticides today. Under the new Section 3 regulation, it has been impossible to register a pesticide for the last 18 months. In 1973, the Department of Agriculture, Department of Forests and Parks, the Aiken Laboratory, and the UVM Experiment Station conducted tests to develop experimental data that would enable the state to register SEVIN for use against insects on maple plantations for maple syrup production. Since maple syrup is a food crop, a tolerance had to be established. The Department ran the experiment using an experimental design considered adequate by EPA, collected the sap and syrup samples, and then used these samples to test for the pesticide in the sap and syrup. No residue was found. The data was sent to EPA with a request that a tolerance be established for Carbaryl in maple syrup. EPA assured us that our work was sufficient to warrant a registration for this use. In the fall of 1976, Carbaryl became a candidate for RPAR so now we are informed that EPA will not issue a tolerance or a new registration for any material that is on the candidate list for RPAR. As of this date, we still do not have a commercially-registered material that may be used on sugar producing maples infested with insects. I am also informed that the RPAR on Carbaryl will not be issued until May. Once the RPAR is issued, if it ever is, there is an approximately 300-day process in determining whether any uses of the compound should be cancelled or suspended. This means Vermont maple syrup producers will have to wait at least two or more years before they will have a material they can legally use on sugar bushes under the current procedures as implemented by the EPA.

I would like to point out that this pesticide can legally be applied to almost anything produced in a home garden with a waiting period prior to harvest of as little as one day on many food commodities.

I am sure you would agree that a nine-month waiting period as we have with maple syrup when we treat sugar bushes in June is sufficient to allow this pesticide to be registered at this time. I might add that Carbaryl is just one of 40 pesticides that are now candidates on the active RPAR list, and it is rumored there are approximately another 60 pesticides that EPA wants or is going to place on the candidate list. It does not take long to see that this is going to bring the development of pesticides for agricultural production to a standstill.

This situation takes on added emphasis when one considers the Office of General Counsel's insistence that the statement as required in Section 12(a) (2) (g) of the law; i.e. “it shall be unlawful for any person to use any registered pesticide in a manner inconsistent with its labeling" because the specific pesticide and specific crop now must be listed on the label.

In the past, we were able to treat under category lists-such as leaf miner on alfalfa-without having the pest specifically mentioned. The application of the above law may make it impossible to find a pesticide that may be used on a minor crop. Congress recognized this possibility in the initial law and included a provision-Section 24(c)—which dealt with special local need registration at the state level. EPA has now decided that states must meet the national criteria in Section 3 Paragraphs 162.8 and 162.11 before a state may register a pesticide for a special local need. The above two sections are main stumbling blocks in registering pesticides at the federal level. It certainly does not make sense to apply them to 24(c) registration which would mean that state government would not be able to register pesticides for special local need.

It should also be pointed out that many of these minor uses do not require the amount of pesticide sufficient to allow the chemical company to recover its costs in registering the pesticide for these uses. Many times the chemical companies register pesticides for minor uses more for a service to the agricultural community than for an economic gain.

I would hope that the Congress would address this issue within the next six months.

(3) The last area of concern I feel that Congress should address is the issue of applicator certification. I feel there are two major problems with certification. First of all, if states continue to certify commercial applicators in the future as required by most state plans, the federal government should continue to provide

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