By Rich Kozlovich
In recent months the bed bug issue has reached headline proportions on the national scene. National television news networks have featured the story, magazines have highlighted the problem nationally and newspapers have focused on local infestations that seem to be out of control and growing. It is almost like one of those overnight movie star sensations who won an award only to find out that he has been in the entertainment business for fifteen years. We, the pest control industry, have known this day was coming for some time, and in point of fact I know one old timer who ominously stated over ten years ago that bed bugs would be back.
After 1994 the Congress made an attempt to fix the Delaney Act, which amended the Federal Food, Drug, and Cosmetic Act of 1938 (FFDCA). The Delaney Clause states that nothing can be used if "it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal". But because it was so extremely complicated and convoluted (made mores so by a court case Les v. Reilly) it was implemented in such a way that it basically declared that if something was carcinogenic at any level it was carcinogenic at every level and nothing that tested carcinogenic could be used in any food additives in processed food.
Since Delaney required zero risk versus negligible risk the whole thing became so perverse that Delaney would forbid the EPA from registering new pesticides that were perceived safer if they tested carcinogenic. This was known as the Delaney Paradox. This clearly had created a regulatory nightmare based on a law that had no basis in real science. Because of this the National Academy of Sciences (NAS) issued a statement in 1987 outlining four principles that pesticide law should meet
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.
This clearly seems to be more than reasonable and justified. Unfortunately the fix ended up being as bad as the problem. Possibly worse because the EPA was being forced by lawsuits to enforce Delaney to its fullest extent, and if that had occurred we might have gotten rid of it entirely, instead we ended up replacing it with another compromise now based on risk assumptions.
The FQPA changed the rules regarding the 100 fold safety factor tied up in pesticides by a potential factor of ten, ratcheting up the safety factor from 100 to a potential of 1000. (This explanation is a “really” shortened and simplified version of this subject. Please go to Frank B. Cross’s extremely well done and lengthy examination of this subject in the article, “THE CONSEQUENCES OF CONSENSUS: DANGEROUS COMPROMISES OF THE FOOD QUALITY PROTECTION ACT”)
At this point I think it worthwhile to explore this issue of carcinogenic testing. The EPA bases it judgment on rodent testing. Make no mistake about this; a mouse isn’t a little man and using rodents that are genetically predisposed to growing tumors for testing and then exposing them massive doses of anything to make that determination isn’t the best science as required under the Information Quality Act.
In 2005 the American Council on Science and Health (ACSH) (As a point of disclosure: I am member of ASCH) petitioned the EPA to “Stop declaring chemicals carcinogens based on rodent tests alone”. ACSH noted that the law permits EPA “to adopt policies that err on the side of caution when faced with genuinely equivocal evidence regarding a substance's carcinogenicity, but the IQA does not permit EPA to distort the scientific evidence in furtherance of such policies.”
The petition argues that EPA ”distorts scientific evidence through its Guidelines' use of "default options," its purported right -- based not on scientific evidence but its regulatory mission to protect human health -- to assume that tumors in lab rodents indicate that much smaller doses can cause cancer in humans. Erring on the "safe side" in regulatory decisions does not, argues the petition, permit EPA to falsely claim that such regulated substances truly are "likely to be carcinogenic to humans." To do so, argues ACSH, is a distortion of both science and law. “
Finally after months of delays the EPA formally responded saying “that their Risk Assessment Guidelines are not statements of scientific fact -- and thus not covered by the IQA -- but merely statements of EPA policy.” My question was then and is now. If EPA policies aren’t based on scientific fact, what are they based on?
In 1950 the legal limit for DDT was seven parts per million. Why? Because they couldn’t test below that; so anything below seven parts per million was zero. As the years went by we have learned how to detect substances at parts per billion, then parts per trillion, then parts per quadrillion and parts per…well…even higher numbers that I can’t recite. At some point we will be able to detect everything in anything. But should that matter? No! At some point the molecular load will be so small that cells will not respond to it. Under Delaney that wouldn’t matter. It was later discovered, mostly through the efforts of Dr. Bruce Ames, that the number of naturally occurring carcinogens was shockingly high. Take for an example the traditional Thanksgiving dinner menu which is filled with carcinogens.
So the goal to fix Delaney was a worthy one, but devastating as it was replaced by the Food Quality Protection Act (FQPA) in August of 1996 by Congress and the Clinton EPA under Carol Browner. This amended FFDCA and the Federal Insecticide, Fungicide, and rodenticide Act which the structural pest control industry also falls under. This ended up being one of the most significant environmental and public health bills passed since the Nixon administration, and most of the Congress didn’t really understand what this was going to mean.
As a result of FQPA we lost (in the U.S.) whole categories of pesticides that had been used for years safely and effectively here and around the world.
Along with all else, the EPA requires pesticides to be re-registered after fifteen years. That means more unnecessary and expensive testing. It costs around $300,000,000 to bring a new pesticide to market. Manufacturers want to make sure that re-registration is worth it to them before they spend millions of dollars more on re-testing. Further testing for what you might ask? Who knows, because after a product has been on the open market for fifteen years you absolutely know what, if any, hazards it represents to humanity or to nature. Most importantly after fifteen years these products have probably gone out of patent. That means there is less value to the primary registrant, and if that is the case, there was no value incentive for the manufacturer to spend millions of dollars more to retest. They then simply pull their registration “voluntarily”.
This is just another way the EPA has found to eliminate pesticides without banning them, which can be a messy process; a process in which they would probably lose. When you ban something you have to show reasons for the ban. You have to have facts, figures and….most importantly….real science. If there is none the product stays. They have avoided all of that through their system of rules which can make it a de facto ban without any messy legal stuff.
Organophosphates, such as Dursban absolutely kill bed bugs; on contact and as well as a residual. But in 1996 the Food Quality Protection Act (FQPA) was passed and that changed all the rules. This national policy under the EPA to create uniform regulations with the stated goal to reduce the use of pesticides based on assumed risks cannot occur without compromising the health of the nation. This national bed bug plague is one of those issues, and the tip of the iceberg. Make no mistake about this; if bed bugs were transmitters of disease such as malaria, yellow fever, encephalitis or West Nile virus we wouldn’t be having this national conversation.
I did have a thought that crossed my mind. I wonder if the decline in bed bugs and the decline in leprosy in western countries ran concurrently. Perhaps that could be an interesting area of study.