In early July 1996, I was returning on a flight from Amman, Jordan, wondering what kind of negotiation we in the Clinton Administration faced in completing the legislative text of what became the Food Quality Protection Act (FQPA). (I had been asked to go to Jordan to visit the Jordanian pesticide regulatory program by a friend who was a senior official at the State Department. The result of my visit may have played a very, very small role in the Middle East peace process -- but that is another story for another time).
Some weeks earlier, I had been approached by Congressional staff members whom I knew from my previous job at the Congressional Research Service (CRS) as the subject area expert on the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and pesticide regulation. I joined the Clinton Administration as a political deputy in the U.S. Environmental Protection Agency’s (EPA) Office of Prevention, Pesticides, and Toxic Substances (OPPTS, now renamed as the Office of Chemical Safety and Pollution Prevention (OCSPP)). Dr. Lynn Goldman was the Assistant Administrator who had recruited me to join the efforts to reform, that is, modernize, the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FFDCA). Over the years since it was enacted in 1958, risk assessment methods and our understanding of possible cancer risks had changed greatly.
Setting the Context
In 1989, the National Academy of Sciences issued a report on “The Delaney Paradox,” examining how the Delaney Clause ironically prevented safer new pesticides from entering the market. After an important court decision (Les v. Riley), EPA was told that even if it was undesirable public policy, the law can only be changed by Congress. As EPA went along with its work, many feared that numerous pesticides might be forced off the market even if, using modern evaluation policies, they presented little risk or were in fact safer than the alternatives.
During this time, advocacy groups were concerned that the then-current law was not protective enough of the possible risks to children’s diets. A simple way to say this is, for purposes of risk assessment: “Children are not little adults,” and supporters emphasized that dietary risk assessments by EPA should pay special attention to possible children’s risk given differences in metabolism, growth stages, and other important physiological characteristics.
This led to another National Academy of Sciences report in 1994 on “Pesticides in the Diets of Infants and Children,” which recommended that pesticide regulation include particular attention and possibly greater regulation of estimated dietary risks from pesticides. Given that the new Assistant Administrator of OPPTS was Dr. Lynn Goldman, a pediatrician, this concern was a priority for the Clinton Administration.
“The Gingrich Revolution”
A less noticed irony, but also important to the history of FQPA, is the change in party control of the House of Representatives, led by Representative Newt Gingrich (R-GA) and the “Contract with America” during the 1994 elections. Unexpectedly, the Republicans had the majority in the House for the first time in 40 years, and they elected Representative Gingrich Speaker of the House.
Much longer stories have been and will be written, but shortly after taking power in the House in January 1995, the Republicans were viewed as letting lobbyists run amok -- even suggesting amendments to environmental laws while lobbyists were sitting on the dais of Committee meetings. By the end of 1995 and going into an election year in 1996, “word was” the leadership, at least on the House Energy and Commerce Committee -- chaired by Representative Thomas Bliley (R-VA) -- was looking for a “green vote” to offset the image of an anti-environment House majority. Led by staff from the office of Chair Bliley and Representative John Dingell (D-MI), who was the senior Democrat on the Committee, a draft of a compromise bill was floated and made its way to my office at EPA.
Meantime, during the previous Congress (103rd Congress, 1993 - 1994), a team of EPA staff, led by Jim Jones (a later even more famous name in EPA pesticide regulation) of the Assistant Administrator’s office, along with staff from the Office of Pesticide Programs (OPP) and the Office of General Counsel (OGC), and staff from the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) (it takes a village), had developed a Clinton Administration bill that did not gather much support during 1994. The legislation did have the core concepts of “fixing Delaney” and including the “reasonable certainty of no harm” standard, and it incorporated strong protections about possible risks from residues in the diets of infants and children.
In the new Congress (the 104th), there was some action during 1995 in the House Agriculture Committee on FIFRA issues related to antimicrobial products, minor uses of pesticides, and ways to prod the registration process to become more predictable and timely (this was before the Pesticide Registration Improvement Act (PRIA)). The FIFRA amendments were not viewed as controversial and were successfully discussed between both sides of the aisle (the Agriculture Committees were much more bipartisan in those days). By itself, that package was not likely to make it through the legislative gauntlet, given the shift in political power on the Hill.
Also in 1995, Carol Browner (the EPA Administrator) cautioned us that successful bipartisan legislation was unlikely, so not much effort should be invested, given other priorities.
The key event came in the late spring of 1996 when we first saw a draft of the legislation floated by the staff of Representatives Bliley and Dingell. It was far from perfect, but it included the core elements of what the Administration had proposed in the previous Congress. Since that earlier bill had been drafted with the coordination of EPA, FDA, and USDA, if it had the essential ingredients, we thought it might be a viable vehicle for further discussion. We also sought comment from some of the influential environmental groups that had been disappointed in the Administration’s legislation in the previous Congress. Suffice it to say, the inclusion of the core elements of a tough standard (reasonable certainty of no harm) and special protections regarding children’s diets made the proposals a “possible” vehicle for further discussion.
We also started to have discussions with the staff of Representative Waxman (D-CA) in the House and Senator Kennedy (D-MA). Representative Waxman was the ranking Democrat on the Energy and Commerce Subcommittee, and Senator Kennedy was the ranking Democrat on the Labor Committee, which had jurisdiction over the FFDCA.
Back to July 1996
To shorten the story, we had intense, long meetings with the various interested parties -- pesticide registrants; environmental groups; trade associations; agency staff at EPA, FDA, and USDA; Congressional staff from the authorizing Committees; and Administration leaders within the agencies and the White House. In an amazingly short time, we came to an agreement over the text, which is now FQPA. Representatives Waxman and Roberts (R-KS -- Chair of the House Agriculture Committee) held a press event about the historic compromise -- even more historic since the two Representatives rarely agreed on significant legislation. Their joint endorsement and statement of support signaled to members of both parties on both sides of Capitol Hill that this was an unusual, and important, compromise. The Congressional staff then recognized the next hurdle: the August recess was approaching fast, and if not enacted into law by then, the delay could be fatal, or at least make matters more complicated, as the multitude of interest groups would likely pick apart and want further changes to the agreement that had been reached. So the rush was on to get the “green vote” to the floor of the House and Senate.
Some last-moment hiccups took a little more time. Senator Lugar (R-IN), the Senate Agriculture Committee Chair, wanted a hearing to at least review the legislation. This was not a huge hurdle, but finding time on the floor was a race against the clock before the August recess. The House was the first to vote on July 23, 1996. The bill was approved with a surprising unanimous roll call vote in the majority-Republican House (the vote was 417-0 with 16 not voting). Unanimous bipartisan support! -- imagine that in today’s world.
Then, with a sprinkling of clarifying (that is, reassuring) pieces of correspondence, the Senate agreed to the House legislation under unanimous consent. (In fact, for any trivia nuts out there, if you watch the C-SPAN video of how long the Senate deliberation lasted at the end of the day on July 24, 1996 -- the request for unanimous consent and agreement clocks in under 30 seconds.)
So with unanimous support in both the House and the Senate, FQPA was approved.
One Last Step
One very important last step was needed before FQPA became law -- the President needed to sign the legislation. That happened at the White House when H.R. 1627 was signed by President Clinton on August 3, 1996.