Setting an Anti-Cancer Policy: Risk, Politics, and the Food Quality Protection Act of 1996
By Dominic P. Madigan
INTRODUCTION
On August 3, 1996, President Clinton signed into law the Food Quality Protection Act (FQPA) of 1996, initiating “the most sweeping changes to pesticide laws since 1978.” Coming at the height of that election year's political season, the FQPA represented a remarkable act of cooperation among Members of Congress of both parties; the Act passed through the House and Senate without a single recorded dissenting vote. More importantly, however, the legislation revised a health and safety doctrine that stood famously--or infamously--at the center of the regulation of pesticide residues in food: the Delaney Clause.
Although the Clause, a provision of the Federal Food, Drug and Cosmetic Act (FFDCA), applied to only a limited class of pesticide residues, by early 1990, it was poised to have a powerful impact on pesticide regulation. The Clause, which is the only enacted “zero risk” ban in U.S. health, safety, and environmental regulations, rests on the assumption that no safe level of exposure to a carcinogen exists. As interpreted by the Ninth Circuit in a key case, Les v. Reilly, the Delaney Clause served to ban absolutely the presence of those carcinogenic pesticide residues falling under its purview.
With the Food Quality Protection Act, Congress instituted two key changes to carcinogenic pesticide regulation. First, the FQPA rendered Delaney inapplicable to carcinogenic pesticide residues. Second, Congress substituted a new standard to govern the regulation of carcinogenic pesticides in place of Delaney's flat ban. The new law permits what can be thought of as a “negligible” risk of exposure to carcinogenic pesticides. Although the Delaney Clause remains in place for food additives, color additives, and animal drugs, the FQPA weakened the significance of the Clause by eliminating its application to pesticide residue in food.
This narrowing of the Delaney Clause marks a critical shift in the regulatory response to a set of competing dynamics lying at the heart of food safety policy. As the House Commerce Committee has acknowledged, “[t]he legal requirements for [pesticide] registration recognize that pesticides are both necessary and potentially harmful.” Like other chemicals added to food, pesticide residues are products of intentional application. The use of synthetic pesticides, together with widespread use of synthetic fertilizers, bears a large measure of credit for the rapid expansion of food production in the years since the Second World War. Although debate over pesticide use is spirited, even those most publicly opposed to pesticide use do not support the elimination of all pesticides from production agriculture. Unlike most other additives to food, however, pesticides kill or disrupt the functioning of living organisms. Pesticides pose risks to human health, including cancer or injury to the nervous, reproductive, endocrine or immune systems.
Seen in this light, the shift from Delaney's zero-risk approach to the FQPA's negligible-risk standard represents a change in attitude toward health risks in the food supply. This Note will focus upon the competing conceptions of risk embodied in the FFDCA in its pre- and post-1996 incarnations. Part II of the Note provides background, describing the regulatory framework established before and after passage of the FQPA. Part III focuses upon the policy and science surrounding the different notions of risk. From a scientific perspective, the new law reflects growing confidence in the abilities of scientists and regulators both to measure and manage health risks in the food supply--including carcinogenic risks. Politically, Congress faced heavy pressure to reconceptualize its response to carcinogenic risk because the Delaney Clause had begun to matter; hundreds of millions of dollars were potentially at stake if Delaney's scope remained defined by Les v. Reilly. Finally, Part IV describes how the political environment in 1996 was particularly conducive to the compromise necessary for passage of the FQPA.
On August 3, 1996, President Clinton signed into law the Food Quality Protection Act (FQPA) of 1996, initiating “the most sweeping changes to pesticide laws since 1978.” Coming at the height of that election year's political season, the FQPA represented a remarkable act of cooperation among Members of Congress of both parties; the Act passed through the House and Senate without a single recorded dissenting vote. More importantly, however, the legislation revised a health and safety doctrine that stood famously--or infamously--at the center of the regulation of pesticide residues in food: the Delaney Clause.
Although the Clause, a provision of the Federal Food, Drug and Cosmetic Act (FFDCA), applied to only a limited class of pesticide residues, by early 1990, it was poised to have a powerful impact on pesticide regulation. The Clause, which is the only enacted “zero risk” ban in U.S. health, safety, and environmental regulations, rests on the assumption that no safe level of exposure to a carcinogen exists. As interpreted by the Ninth Circuit in a key case, Les v. Reilly, the Delaney Clause served to ban absolutely the presence of those carcinogenic pesticide residues falling under its purview.
With the Food Quality Protection Act, Congress instituted two key changes to carcinogenic pesticide regulation. First, the FQPA rendered Delaney inapplicable to carcinogenic pesticide residues. Second, Congress substituted a new standard to govern the regulation of carcinogenic pesticides in place of Delaney's flat ban. The new law permits what can be thought of as a “negligible” risk of exposure to carcinogenic pesticides. Although the Delaney Clause remains in place for food additives, color additives, and animal drugs, the FQPA weakened the significance of the Clause by eliminating its application to pesticide residue in food.
This narrowing of the Delaney Clause marks a critical shift in the regulatory response to a set of competing dynamics lying at the heart of food safety policy. As the House Commerce Committee has acknowledged, “[t]he legal requirements for [pesticide] registration recognize that pesticides are both necessary and potentially harmful.” Like other chemicals added to food, pesticide residues are products of intentional application. The use of synthetic pesticides, together with widespread use of synthetic fertilizers, bears a large measure of credit for the rapid expansion of food production in the years since the Second World War. Although debate over pesticide use is spirited, even those most publicly opposed to pesticide use do not support the elimination of all pesticides from production agriculture. Unlike most other additives to food, however, pesticides kill or disrupt the functioning of living organisms. Pesticides pose risks to human health, including cancer or injury to the nervous, reproductive, endocrine or immune systems.
Seen in this light, the shift from Delaney's zero-risk approach to the FQPA's negligible-risk standard represents a change in attitude toward health risks in the food supply. This Note will focus upon the competing conceptions of risk embodied in the FFDCA in its pre- and post-1996 incarnations. Part II of the Note provides background, describing the regulatory framework established before and after passage of the FQPA. Part III focuses upon the policy and science surrounding the different notions of risk. From a scientific perspective, the new law reflects growing confidence in the abilities of scientists and regulators both to measure and manage health risks in the food supply--including carcinogenic risks. Politically, Congress faced heavy pressure to reconceptualize its response to carcinogenic risk because the Delaney Clause had begun to matter; hundreds of millions of dollars were potentially at stake if Delaney's scope remained defined by Les v. Reilly. Finally, Part IV describes how the political environment in 1996 was particularly conducive to the compromise necessary for passage of the FQPA.
