FPQA, FIFRA, and the Delaney Clause

U.S. Legislative Actions 

Sheldon Krimsky/ Hormonal Chaos 2000 

Hormonal Chaos
Sheldon Krimsky 
Johns Hopkins University Press 2000
Chapter 2:  Emergence of a Public Hypothesis p.68-74 

Between 1993 and 1994 eight bills were introduced into the House and Senate that included provisions related to environmental endocrine disrupters. In 1996 the 104th Congress saw six pieces of legislation (three of them associated with amendments to the Safe Drinking Water Act) that addressed the issue of environmental estrogens. For the most part, these bills focused on two themes: research and testing programs.

The Women's Health Environmental Factors Act (H.R. 3509) mandated the Department of Health and Human Services, through the National Institutes of Health, to issue a report on the effects of environmental factors on women's health, specifying that the report should include coverage of "compounds that mimic human estrogens." Another bill, amending Title XIV of the Safe Drinking Water Act (H.R. 3293), added a section titled "Establishment of Screening Program for Estrogenic Substances." Under the bill, the administrator of the EPA, in consultation with the Secretary of Health and Human Services, was required to develop a screening program to determine whether chemicals in commercial use might have effects similar to those of naturally occurring estrogens.

The Omnibus Civilian Science Authorization Act of 1996 (H.R. 3322), passed by the House in September 1996, was the major federal appropriations bill for science. One section, the Endocrine Disrupter Research Planning Act of 1996, required additional coordinated research "to more accurately characterize the risks of endocrine disrupters." Language in the act emphasized the dilemma associated with the environmental endocrine hypothesis, since "neither a conclusion that endocrine disrupters pose an imminent and serious threat to human health and the environment, nor a conclusion that the risks are insignificant or exaggerated, is warranted based on the present state of scientific knowledge." This bill required the EPA to coordinate research in the field of endocrine disrupters, to ensure that risk assessment measures were taken in approving or denying chemical registration, and to see that the research was conducted in a scientific and reasonable manner.

A bill introduced in 1993 and reintroduced in subsequent congresses to amend the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug and Cosmetic Act (H.R. 1627), known as the Food Quality Protection Act (FQPA), was reported favorably out of the Subcommittee on Health and the Environment and the Committee on Agriculture in July 1996 and signed into law on August 6, 1996. Language in the bill gives the administrator of the EPA authority to "require data

or information pertaining to whether the pesticide chemical may have an effect in humans that is similar to an effect produced by naturally occurring estrogen or other endocrine effects."

During the 1995 hearings on the FQPA before the House Subcommittee on Health and the Environment, Erik Olson, senior attorney for the Natural Resources Defense Council (NRDC), one of the nation's most aggressive antipesticide public interest groups, used the DDT experience and evidence from wildlife studies as justification for rewriting the pesticide laws: "Due to pollution from DDT (banned in the 1970s, but still 'out there') and other environmental estrogens, male wildlife are literally being 'feminized': born hermaphroditic with reproductive parts of both sexes or even female entirely." Quoting a Stanford endocrinologist, Olson used the evocative imagery that humans "might be drowning in a sea of estrogens," while emphasizing the additive and synergistic effects of these compounds: "One study was conducted, for example, on the acute toxic interactions of 13 organophosphorus pesticides. The investigators found that 21 pairs had additive toxicity, 18 pairs had less than additive toxicity, and four pairs had synergistic toxicity. `8

The provisions in the FQPA and the amendments to the Safe Drinking Water Act that call for a screening program for estrogenic chemicals were largely the work of New York Senator Alphonse D'Amato, with support from Senator Daniel Moynihan of the same state. D'Amato's home constituency was Long Island, where breast cancer rates were elevated relative to those in other parts of the state. The activism of Long Island women organized around the issue of breast cancer was a key factor in focusing D'Amato's attention on the issue of estrogenic chemicals and ultimately in winning his support for the screening program. The influential National Breast Cancer Coalition had not played an active role in lobbying for an endocrine disrupter screening program; it focused instead on gaining increased funding for breast cancer research. Now the elevated breast cancer rates on affluent Long Island and in some Massachusetts communities became the stimulus for a new wave of political mobilization among women with the disease.

In 1990 a group of women calling itself One in Nine began lobbying for a comprehensive federal study of breast cancer incidence on Long Island. The group urged the Centers for Disease Control in Atlanta to undertake the study but did not receive a satisfactory response. The leadership of One in Nine spoke to representatives of the National Cancer Institute (NCI) and were told that such a study would cost $5 million. Moreover, institute representatives made it clear that they did not want politics involved in a breast cancer study. Nevertheless, One in Nine President Geri Barish could not imagine raising $5 million without the help of politicians. She approached D'Amato and with members of her board argued the case for the Long island breast cancer study. D'Amato was responsive to their concerns. According to Barish: "He got us the $5 million from the Department of Defense .... After we got the $5 million, the very next day after it was announced that the money was awarded, the NCI pulled out. They said they would not do the study. We called Senator D'Amato and within one hour he called back and said [NCI] is doing the study."'9 The study eventually exceeded the $5 million estimate, and D'Amato found another $15 million to complete the task.

The pursuit of this study was only one part of a larger program of advocacy by One in Nine on behalf of breast cancer victims. Its members lobbied for raising the overall level of research funding for breast cancer and for tighter regulation of pesticides and pesticide residues in food. The Long island women believed that pesticides might explain the elevated incidence of breast cancer in their region. Federal funding for breast cancer research went from $90 million in 1990 to nearly $500 million five years later in large part because of the political mobilization of breast cancer activists.

D'Amato testified before a joint hearing of the Senate and the House in September 1993, raising the issue of estrogenic chemicals as a possible cause of cancer. He cited the studies of Devra Davis (then at the Department of Health and Human Services), who had worked closely with breast cancer activists, and Mary Wolff at the Mount Sinai Medical Center. It was at these hearings that D'Amato first proposed the idea of testing chemicals for estrogenicity: "Now it appears that there may be a number of environmental agents-pesticides and other chemicals with estrogenic properties-that are capable of increasing a woman's lifetime exposure to estrogen and thus increasing the risk of breast cancer. I believe it is vital that the administration's pesticide bill include provisions requiring routine screening of pesticides for estrogenicity . . . . It is my intent to work on drafting provisions that will mandate estrogenic testing of pesticides."20

Two years later, in his statement before the Senate on the FPQA on November 29, 1995, D'Amato revisited the estrogenic testing amendment: "I want to commend and thank the managers of this bill for including in the manager's amendment package our amendment establishing an estrogenic chemical screening program at EPA .... This amendment is critical in view of growing evidence linking environmental chemicals that are capable of mimicking or blocking the action of the hormone estrogen to a host of developmental and reproductive abnormalities in wildlife and

humans. The most alarming findings suggest a link between exposure to these chemicals and the dramatic increase in human breast cancer that has become so tragically apparent in our Nation over the past several decades.""

D'Amato again cited the findings of Mary Wolff of the Mount Sinai Medical Center that higher serum levels of PCBs and DDE were correlated with higher risk of developing breast cancer, suggesting that exposure to estrogenic organochlorines might affect the incidence of hormone-responsive breast cancer. Wolff had testified five months earlier before the House Subcommittee on Health and the Environment that "hormonal disruption may be associated with a broad range of biological effects: reproductive dysfunction, neurological problems, and immunological difficulties" and that endocrine disrupters might be implicated in cancers of the breast, prostate, uterus, ovaries, and colon."

The suspected link between endocrine disrupters and cancer was cited by the Committee on Agriculture in its report on the FQPA: "The Committee is aware of recent scientific reports indicating that some pesticides may initiate, enhance, or block the activity of hormones in humans and wildlife. For example, a linkage has been suggested between human exposure to chemicals that imitate estrogen and breast cancer. Since hormones govern fundamental biological functions such as reproduction, growth, and metabolism in humans and other species, the Committee believes that it is important for EPA to obtain data about the potential hormone-disrupting effects of pesticides in order to make informed regulatory decisions under FIFRA." But the committee did not support a separate amendment to the FQPA calling for the screening of chemicals for endocrine effects. Instead, it said, "The Committee has reviewed and considered the issue and has determined that the EPA currently has sufficient authority to request information related to such effects .... Therefore, the Committee expects the Agency, within four years of the date of enactment of this Act, to evaluate the need for and, if necessary, to use its existing authority under sections 3 and 4 of FIFRA to establish standards for data requirements, to determine whether a pesticide can disrupt hormonal activity. "Z3

Committee member Congressman George Brown stated his minority view that the endocrine-testing amendment should be included in the bill and highlighted the concern about a breast cancer link to endocrine disrupters: "During the Committee markup I offered, and subsequently withdrew, an amendment to require EPA to develop a data standard for hormonally active pesticides under existing authorities in sections 3 and 4 of FIFRA. These substances, commonly referred to as endocrine disrupters, are believed to interfere with fundamental biological functions such as reproduction and development in humans and other organisms. A link to some types of breast cancer has also been suggested. "14 Brown indicated that he would pursue the statutory amendment on endocrine testing over the committee's negative recommendation when the bill was brought before the House. The House Committee on Commerce, which reported favorably on the FQPA on July 23, included an estrogenic substances screening amendment to the bill. The bill passed the Senate with little opposition.

The screening amendment went further than empowering the EPA administrator to assess endocrine effects; it established a strict timetable: "Not later than 2 years after the date of enactment of this section, the Administrator shall in consultation with the Secretary of Health and Human Services develop a screening program. ',2' The screening and testing strategy was to be implemented in the third year and a program report submitted to Congress by the end of the fourth year. This timetable was particularly problematic, because the science for identifying and screening endocrine-modulating chemicals was as yet still in its infancy. The language in the bill put considerable pressure on the EPA to develop a consensus among scientists in an area replete with uncertainty (see Chapter 4).

When the FQPA passed, there were certainly many skeptics within the scientific community who did not believe that ambient levels of industrial and agricultural chemicals were affecting human health by interfering with endocrine functions. The leading journal on the human endocrine system, Endocrinology, barely took notice of the hypothesis. Representatives of the industrial sector called the theory that our hormones are under attack a fanciful notion created by environmentalists to bring about a ban on chlorinated compounds and other persistent organic pollutants. Two international protocols in the process of negotiation under the auspices of the United Nations Economic Commission for Europe were prepared through the U.N. convention on long-range transboundary air pollution. The protocols currently cover 16 substances, some of which are known or probable endocrine disrupters.

Yet beyond the initial antienvironmental posturing of certain industrial groups, there was very little opposition to the provision in the new pesticide law requiring screening for endocrine disrupters. Part of the reason for the low level of response in the industrial sector may be found in the issue that had consumed much of their concern over the past decade, namely pesticides and the Delaney clause. First introduced into the Food and Drug Amendments of 1958, the Delaney clause required zero tolerance for food additives that had been shown to be human or animal carcinogens at any dose. The zero-dose standard, however, was never applied to pesticide residues, which could still be found in both fresh and processed food.

The NRDC commenced litigation against the EPA in 1992 on the grounds that Delaney should be applied to pesticide residues, since they are a kind of food additive. Many pesticides then in use would have had to be withdrawn under the Delaney standard. The NRDC's case was eventually upheld by a federal district court, and, through consent decrees based on its court victory, the NRDC was able to increase pesticide prohibitions.

Actions taken by the executive and legislative branches to find a compromise between industry and environmental interests eventually proved successful. Industry spokespersons argued for the replacement of the "zero-risk" standard by a "negligible risk" standard. Environmentalists, on the other hand, wanted to raise the safety standards for pesticide residues in food, especially for infants and children.

The resulting legislation within the FQPA was one of the least contested environmental acts passed in decades. In the end it was supported by 55 interest groups, including representatives of the agricultural industry, food processors and distributors, and environmental groups. The Committee on Commerce voted 45-0 in support of the FQPA, with the endocrine screening amendment. The bill was passed by a vote of 417-0 in the House on July 23, 1996, and by unanimous consent of the Senate on July 24.

The passage of the FQPA was a victory for stakeholder negotiations as an approach to resolving environmental controversies. Not surprisingly, a few environmental groups (including the Public interest Research Group and the National Coalition Against the Misuse of Pesticides) opposed the loss of the Delaney zero-risk standard and the emphasis on single pesticide effects, in light of newly publicized reports of chemical synergisms that could increase risk (see Chapter 3). But these broadly supported legislative initiatives on endocrine disrupters are noteworthy for having been initiated well in advance of publication of an influential popular book on the subject, and for not having been prompted by a blockbuster media event or catastrophe, such as the revelation of the toxic waste dump at Love Canal or the chemical spills at Bhopal, India, and Seveso, Italy.

Supported by a small group of stakeholders and influential scientists, the endocrine disrupter screening program was one of the uncontested throw-ins of the new legislation-one that was not perceived to pose any immediate threat to industry. in the context of the major points contested in the FQPA debate, related to pesticides and the Delaney clause, little public attention was directed at a brief provision in the bill titled the "Estrogenic Substances Screening Program." Under the program, the EPA had three years from the date of enactment to determine whether certain substances "may have an effect on humans that is similar to an effect produced by naturally occurring estrogen, or other endocrine effect as the Administrator may designate.""

Even if there were any doubts about the public's support for taking a serious look at endocrine disrupters, they would disappear after the publication of Our Stolen Future in March 1996.