Knowing of your interest in the export and import of agricultural commodities, I want to update you on developments in consultations between pesticide regulatory officials in the United States and Mexico.

Many issues arise as a consequence of the extensive trade in agricultural commodities and pesticides across international borders. In recent years one of the major international issues has concerned the presence of pesticide residues in food. The need to use effective agricultural pesticides must be balanced against the need to also meet standards of food quality and safety established to protect consumers. These potentially conflicting necessities have created difficulties in the export and import of food. Α number of countries, including the U.S., have devoted significant effort to international organizations, such as the Codex Alimentarius Commission, the Joint Meeting on Pesticide Residues (JMPR), and others, dedicated to the international harmonization of pesticide residue limits.

The problems arising from the presence of pesticides in food are particularly pressing and important to resolve between neighboring countries such as the U.S. and Mexico where differences in food standards may artificially restrict the exchange of agricultural commodities.

In the U.S., the Environmental Protection Agency (EPA) evaluates and registers pesticides for use under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended, and establishes tolerances or legally acceptable residue levels for pesticides applied to food crops under

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the Federal Food, Drug and Cosmetic Act (FFDCA). EPA decides whether to grant tolerances and register pesticides primarily on the basis of scientific studies conducted by a tolerance petitioner or registration applicant. The Food and Drug Administration (FDA) inspects food moving in interstate commerce, including imported food, and may seize, or deny entry into the U.S., shipments bearing pesticide residues for which no tolerance exists or which exceed a tolerance.

In addition, FIFRA authorizes EPA to issue permits for experimental uses of pesticides. When sufficient data are available, EPA establishes temporary tolerances to allow marketing of the experimentally treated crop. EPA may also grant emergency exemptions from full registration requirements when requested by State or Federal agencies to permit use of pesticides to meet unanticipated pest control needs. Several hundred such exemptions annually permit U.S. growers to apply pesticides which usually have been registered for other crops or have been used experimentally but which have not been registered for the exempted use.

Because of climatic and biological differences between the United States and Mexico, different agricultural pest problems arise in the United States which may be treated with pesticides not evaluated and registered for that use in Mexico and for which appropriate tolerances may not be established. Likewise, pesticides permitted for use in Mexico may not always be approved for use in the United States. Consequently, agricultural commodities grown in one country and intended for export to another, may bear residues of pesticides not considered or fully approved for use in the importing country, even though such residues may pose legal rather than health problems. Thus, tolerances, which are intended to preserve food quality and protect public health, may also create artificial trade barriers.

Beans grown

A recent example illustrates this problem. in this country were treated with the desiccant paraquat to hasten harvesting under an emergency exemption issued by EPA. A maximum residue level was established to permit marketing in the U.S. and to protect the health of consumers, based upon expected residues, toxicological considerations, dietary habits of the U.S. population, and other dietary exposures to paraquat. However, some of these paraquat-treated beans were intended for export to Mexico which had not fully approved this use of paraquat or established its own acceptable residue level. Consequently, Mexico did consider prohibiting the marketing of these beans. However, in this case, the problem is being resolved by an exchange of information on the conditions

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of the emergency exemption and the kinds of human health issues EPA evaluated in approving this emergency use of paraquat.

Since this is not a unique, nor a unilateral problem, Mexico is seeking informal U.S. approval for residues in crops which are treated under emergency exemptions in Mexico after an evaluation of health effects. The government of Mexico has furnished us with an initial list of pesticides which are candidates for emergency use. Mexico also proposes to advise us prior to or at the time they authorize use so that a risk assessment could be performed before the treated crop arrives at a U.S. port of entry. Mexico would provide our scientists with information they possess about the chemical and its behavior to facilitate the assessment. So long as the basic purpose of the Food, Drug and Cosmetic Act, to protect consumers from unsafe residues is met, EPA and FDA are inclined to acceed to the wishes of the Mexican government for chemicals already registered for other uses, used experimentally, or used under emergency exemptions in the United States.

We believe this policy will complement EPA and FDA ongoing efforts for assuring that the Mexican government recommends only pesticides which the U.S. government considers safe. This will also assure that residues present on imported Mexican food comply with EPA prescribed limits. The Mexican government has been working to gain better control over what pesticides their growers use, thus reducing the instances in which growers may resort to the illegal use of pesticides whose hazards may not be adequately assessed or which may pose unreasonable risks to human health. But, to maintain this better control, the Mexican government must also be able to help their farmers save their crops in a pest emergency, as we do in the U. S., by permitting careful use of pesticides which may not have a specific registration for a particular use. There must also

be some assurance that the pesticide-treated crop will still be marketable. Thus our new policy should, by supporting the efforts of the Mexican government, result in better protection for U.S. citizens.

The policy should also guard against providing growers in Mexico with a competitive advantage over U.S. growers, since in most cases the pesticides involved should also be available to U.S. growers if necesary to the successful production of their crops. However, in developing this policy EPA and FDA have been chiefly concerned about protecting the health of U.S. consumers of the Mexican crops. We realize

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that there are other issues of an economic and commercial nature which exist independent of this policy, and which are outside our expertise to address. The U.S. Special Trade Representative, the Departments of Agriculture and Commerce, and the appropriate Congressional committees may wish to consider the more purely economic aspects.

We are therefore advising the Government of Mexico that we are prepared to consent, on a limited basis, to their request. I emphasize that we will not be allowing residues of pesticides which have been cancelled in the United States, unless perhaps emergency exemptions for such use have been granted in this country as well. Further, we are also expecting that Mexico will continue to extend the same kind of consideration to U.S. crops bearing residues of pesticides not fully approved for use in Mexico, as they are doing with the paraquat-treated beans.

I would be interested in any thoughts you would care to share with us about these developments.

Edwin

Edwin L. Johnson

Sincerely yours,

очерь

Deputy Assistant Administrator for Pesticide Programs

Environmental Protection Agency

Pitics

Joseph P. Hile

Associate Commissioner for Regulatory Affairs Food & Drug Administration

I appreciate the opportunity to provide you and your committee with a current statement of the Department's activities in reducing toxic chemicals in the food supply. There have been many positive steps taken since the report, "Cancer Causing Chemicals in Food", referred to in your letter of January 5, was issued in December 1978 by the Subcommittee on Oversight and Investigations of the then Committee on Interstate and Foreign Commerce. Also, we have learned how the residue program of the Food Safety and Inspection Service (FSIS) may be integrated more effectively with the Extension Service, agricultural producer organizations and the drug industry to resolve residue problems. As a result of these activities, the level of known human exposure to toxic chemicals from the meat and poultry supply has been substantially reduced.

Sulfonamide Residues in Swine

The

The 1978 Subcommittee report identified a sulfonamide violation rate of 10-15 percent in swine as one of two major concerns about known residue exposures. A departmental study, including additional research and the work of USDA epidemiologists, clearly defined several factors contributing to the problem, and this information was provided to producers through the Extension Service education programs. One important factor was the cross-contamination of withdrawal (non-medicated) feed following the preparation of medicated feed. drug industry changed the particle size of the drug used in preparing finished feeds to a granular form which has helped to alleviate the problem. Educational programs have increased producer awareness of this residue problem and provided specific information about on-farm precautions that must be taken if sulfonamides are to be used safely. These programs have been very effective (Appendix 1). For example, in States that continued to show a high violation rate, we found few producer educational programs in effect. After we began operating special programs (spotlighting) in cooperation with state officials, the violation rate declined sharply (Appendix 2). At present the national sulfonamide violation rate in swine is between 4 and 6 percent; we anticipate further reductions as our educational efforts continue.