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The Delaney Paradox And Negligible Risk 8/91

The Delaney Paradox And Negligible Risk 8/91

The Environmental Protection Agency (EPA) regulates pesticides under two laws, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). FIFRA requires that pesticides be licensed or "registered" with EPA prior to sale and use in the United States. The FFDCA gives EPA the authority to set legally enforceable limits, or "tolerances" for pesticide residues in foods. The FFDCA specifies that a food containing a pesticide for which no tolerance has been established, or with a residue exceeding an established tolerance, is considered adulterated and subject to seizure. EPA sets tolerances for pesticide residues remaining in raw foods under section 408 of the FFDCA. Under section 409 of the FFDCA, EPA sets food additive tolerances for pesticide residues which concentrate in processed foods above raw food tolerances, or are the result of pesticide application during or after food processing.

EPA's task of regulating pesticides and their residues in foods has been complicated by the different standards in FIFRA and FFDCA, and the different standards within the FFDCA itself. In particular, section 409 of the FFDCA contains the "Delaney Clause" which, when read literally, absolutely prohibits the establishment of food additive tolerances where evidence indicates that the pesticide may cause cancer in humans or animals, no matter how small or minimal the risk. On the other hand, FIFRA requires EPA to weigh the risks and benefits of a pesticide when deciding whether to allow the continued use of that pesticide. Similarly, section 408 of the FFDCA requires EPA to consider the necessity for the production of an adequate, wholesome and economical food supply in setting tolerances. Thus, in contrast to the Delaney Clause, FIFRA and section 408 of the FFDCA require consideration of the level of risk and the benefits of pesticide use.

This inconsistency in standards has been called the "Delaney Paradox" by the National Academy of Sciences (NAS), an expert non-governmental body. In 1985, EPA commissioned the NAS to examine the scientific and regulatory implications of the varying food safety standards contained in FIFRA and the Delaney Clause of the FFDCA. One result of the inconsistency is that the same pesticide residues which may be legal on a raw food could render a processed food unacceptable under the law. Under these circumstances, for example, EPA could set a section 408 tolerance for apples for a pesticide that posed a negligible risk of cancer. But if the apples were processed into apple juice and pesticide residues became concentrated to higher levels than in the raw commodity, (Various processes such as milling, drying, or juicing in some cases cause the relative amount of pesticide to increase in the processed food as compared to the raw food. For example, in drying, the ratio of the amount of pesticide to the rest of the food could increase as water is removed. Concentration of residues does not necessarily make a food unsafe for consumption because dietary exposure to a pesticide depends on the concentration of pesticide remaining on food and the quantity of food consumed.) then under a strict interpretation of the Delaney Clause, EPA could not set a section 409 tolerance for processed apples. As a matter of practice, EPA would then decline to set a section 408 tolerance for the pesticide in raw apples because it would be difficult to ensure that treated apples would not be processed into apple juice. Consequently, EPA would not allow use of the pesticide on apples at all, even if EPA believed that it was as safe as other apple pesticides already on the market.

In 1987, the NAS issued its study of the Delaney Clause, and reached four principal conclusions:

  1. All pesticides should be regulated on the basis of a consistent standard, so that there is no "double standard" for raw vs. processed foods or for old vs. new pesticides. The NAS found no public health reasons for treating residues on raw or processed foods differently.

  2. A uniform "negligible risk" rather than a "zero risk" standard for carcinogens in food, consistently applied, would best enable EPA to improve the overall safety of the food supply, and would result in only modest reductions in the benefits of pesticide use to farmers.

  3. EPA should set its regulatory priorities by focusing first on the most worrisome pesticides used on the most-consumed crops.

  4. The Agency should adopt a comprehensive analytical framework for forecasting the broad-scale impact of its pesticide-specific regulatory actions on the overall safety of the food supply.

Based on these conclusions, EPA has attempted to implement a consistent negligible risk standard under each of the provisions of the laws governing pesticides. In the case of FIFRA and FFDCA section 408 which require risk/benefit balancing, EPA has treated risk in the range of 1 in 1 million (meaning that, at most, an individual would have a one in one million chance of developing cancer if exposed over a lifetime) as a reference point and required that substantial benefits be demonstrated for any risk which exceeds that level. As to the Delaney Clause, EPA has adopted an interpretation which does not prohibit the establishment of food additive regulations posing a de minimis risk (a risk so minimal that it is not worth considering). These two actions, while not completely equivalent, allow for each of the standards under the various provisions to be substantially more compatible.

EPA's interpretation of the food additive laws was challenged in a petition filed on May 25, 1989 by the State of California, the Natural Resources Defense Council (NRDC), Public Citizen, the AFL-CIO, and several individuals. The petition requested that EPA revoke 14 food additive regulations for 7 pesticides. The petitioners argued that the food additive regulations should be revoked because the pesticides to which the regulations applied were probable or possible animal carcinogens and thus the regulations violated the Delaney Clause. On February 19,1991, EPA issued a Final Order upholding its interpretation that the law supports a de minimis exception to the Delaney Clause for pesticide uses which create at most a de minimis risk. In applying this de minimis standard, EPA declined to revoke several food additive tolerances but found that two food additive tolerances exceeded a de minimis level and would have to be revoked. The petitioners have sought review of this decision in federal court.

EPA has been working with the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA) to develop legislation, as part of the President's Food Safety Plan, which would amend FIFRA and FFDCA to establish a consistent "negligible" risk standard for evaluating the safety of pesticide residues in raw and processed foods. Additional information is available from EPA on the provisions of the President's Food Safety Plan.

U.S. EPA, For Your Information, 8/91