WEBVTT 00:01.540 --> 00:03.580 Prof: Today I want to talk about the relationship 00:03.584 --> 00:04.444 between risk and law. 00:04.440 --> 00:08.400 And I want to do this in the context of the history of 00:08.397 --> 00:12.647 agriculture and regulating pesticides during the twentieth 00:12.653 --> 00:13.553 century. 00:13.550 --> 00:18.580 And also I want to have you consider the idea of risk. 00:18.580 --> 00:24.610 And I'm reminded as I think about this of T.S. 00:24.610 --> 00:26.440 Eliot's line, "Only those who will risk 00:26.435 --> 00:29.105 going too far can possibly find out how far one can go." 00:29.110 --> 00:33.010 So many believe that environmentalists are in the 00:33.012 --> 00:37.812 business of trying to absolutely minimize risk as opposed to 00:37.809 --> 00:41.789 balance the threat of loss or danger against other 00:41.793 --> 00:43.423 opportunities. 00:43.420 --> 00:47.140 And others argue that without risk in life, 00:47.137 --> 00:49.967 things would be pretty boring. 00:49.970 --> 00:54.630 I was traveling through Europe last summer on a lecture tour, 00:54.634 --> 00:58.914 and I saw this village sitting on the top of a cliff. 00:58.910 --> 01:03.730 And I wondered to myself about the village, and I wondered how 01:03.732 --> 01:08.242 they chose to build so close to the edge, and what kind of 01:08.239 --> 01:10.769 thinking was in their minds. 01:10.769 --> 01:14.959 And I could imagine that this used to be a number of fields 01:14.956 --> 01:17.696 where they grazed cattle and sheep, 01:17.700 --> 01:21.150 and they probably worried about losing cattle and sheep across 01:21.150 --> 01:21.830 the cliff. 01:21.830 --> 01:25.550 Then as it grew into a little village, I can imagine them 01:25.549 --> 01:29.069 worried about their children playing near the edge. 01:29.069 --> 01:33.709 So much of environmental law is about thinking about the buffer 01:33.714 --> 01:38.214 zone or the safety factor that you would want to use to offer 01:38.209 --> 01:42.179 sufficient protection against significant damage. 01:42.180 --> 01:47.770 So the idea of risk and understanding risk is really a 01:47.765 --> 01:52.925 fundamental aspect of human logic and instinct. 01:52.930 --> 01:59.990 Within law, it tends to become defined as probability of loss, 01:59.991 --> 02:02.771 probability of damage. 02:02.769 --> 02:06.059 It might be an endangered species, it might be air 02:06.061 --> 02:08.481 quality, it could be human health. 02:08.479 --> 02:12.029 And it's often expressed in both quantitative and 02:12.030 --> 02:13.510 qualitative terms. 02:13.508 --> 02:17.238 So particularly over the past thirty years, 02:17.240 --> 02:20.870 the field of quantitative risk assessment has grown in 02:20.866 --> 02:25.106 importance to try to understand what happens to chemicals or to 02:25.110 --> 02:28.300 species, what kinds of pathways they 02:28.301 --> 02:31.741 travel, what kinds of problems might 02:31.738 --> 02:36.598 occur from chemical release and chemical movement. 02:36.598 --> 02:39.728 And increasingly, it's more sophisticated 02:39.730 --> 02:42.370 mathematically, and more difficult to 02:42.365 --> 02:46.095 understand the different sources of uncertainty that are embedded 02:46.098 --> 02:47.848 in these estimates of risk. 02:47.848 --> 02:52.258 You may have heard of the idea of an acceptable risk level for 02:52.264 --> 02:56.394 cancer or some other undesirable outcome as being one in a 02:56.390 --> 02:57.260 million. 02:57.258 --> 03:00.228 Well, the government has used that standard on many occasions: 03:00.229 --> 03:02.419 a "one-in-a-million excess risk." 03:02.419 --> 03:05.619 Well, to put that into perspective, you might think 03:05.621 --> 03:07.351 about the H1N1 infection. 03:07.348 --> 03:14.388 So what was the actual morbidity rate over the past 03:14.387 --> 03:16.637 year for H1N1? 03:16.639 --> 03:20.159 Well, it turns out that you would first think about the 03:20.157 --> 03:24.127 number of people in the United States, say roughly 300 million 03:24.133 --> 03:24.853 people. 03:24.848 --> 03:29.018 And you'd want to know what the incidence rate was in the 03:29.024 --> 03:29.774 illness. 03:29.770 --> 03:31.890 And those now, I was looking at them last 03:31.894 --> 03:35.404 night on the Centers for Disease Control and Prevention website. 03:35.400 --> 03:41.000 Their estimate is that between 30 and 45 or 50 million people 03:41.001 --> 03:46.231 carried the virus and had some adverse effect from it. 03:46.229 --> 03:50.439 And then I was looking at the statistics for mortality. 03:50.440 --> 03:57.930 And between 15 and 20,000 people were killed by the 03:57.931 --> 03:59.431 illness. 03:59.430 --> 04:02.010 Why the uncertainty associated with the estimate? 04:02.008 --> 04:05.468 Well, it's an illness that can harvest, so to speak, 04:05.471 --> 04:08.591 in epidemiological terms, the more susceptible, 04:08.593 --> 04:11.923 those that have serious background illnesses. 04:11.919 --> 04:16.459 So the expression of risk for morbidity, 04:16.459 --> 04:22.019 which means illness, would be roughly let's say 30 04:22.016 --> 04:27.636 million out of 300 million, which is really quite striking. 04:27.639 --> 04:31.319 There are few illnesses that have that rate. 04:31.319 --> 04:34.419 So roughly a one-in-ten risk. 04:34.420 --> 04:37.740 And I mentioned when I started this brief aside that a 04:37.742 --> 04:41.382 one-in-a-million risk is often thought of as acceptable. 04:41.379 --> 04:45.499 The distinction between environmental risks that are not 04:45.495 --> 04:49.755 biologically based or generated by pathogens like H1N1 and 04:49.759 --> 04:53.649 chemical risks is often that there was a clear causal 04:53.649 --> 04:57.839 relationship between exposure and an understanding of the 04:57.839 --> 05:02.419 source of the illness, and also what might be done to 05:02.416 --> 05:06.036 manage it more effectively, such as the vaccine. 05:06.040 --> 05:08.440 By the way, the vaccine that was produced and distributed 05:08.440 --> 05:10.200 this year was really pretty remarkable. 05:10.199 --> 05:13.289 It was extremely effective, and the incidence rate was 05:13.293 --> 05:16.623 projected to be far higher than it actually turned out. 05:16.620 --> 05:23.390 So this concern over quantitative risk assessment, 05:23.389 --> 05:26.159 try and understand who's most vulnerable, 05:26.160 --> 05:30.420 who's going to basically sustain the most serious 05:30.423 --> 05:32.563 effects, this preoccupies the 05:32.555 --> 05:35.465 Environmental Protection Agency, the Food and Drug 05:35.473 --> 05:38.613 Administration when they're thinking about allowing a new 05:38.613 --> 05:40.803 drug to be added to the marketplace. 05:40.800 --> 05:44.260 And really, the decision is all about balancing, 05:44.259 --> 05:47.899 trying to think through what the quality of the evidence is 05:47.899 --> 05:51.539 and should the dangers be balanced against the benefits. 05:51.540 --> 05:55.190 And this standard for balancing has shifted dramatically over 05:55.190 --> 05:56.650 the twentieth century. 05:56.649 --> 06:00.929 So that the lecture today really will trace the evolution 06:00.934 --> 06:05.144 of law and demonstrate how it's shifted from 1906 to the 06:05.141 --> 06:06.061 present. 06:06.060 --> 06:09.570 And I want you to think about how it really reflects changing 06:09.572 --> 06:12.092 science as well as changing human values. 06:12.088 --> 06:14.768 So that as the science gets stronger, 06:14.769 --> 06:18.859 we understand the relationship between an exposure and an 06:18.863 --> 06:22.653 adverse outcome and oftentimes, the government will intervene 06:22.651 --> 06:24.541 by setting a new law or a new regulation. 06:24.540 --> 06:32.330 So that back in 1906, the Pure Food and Drug Act of 06:32.327 --> 06:40.427 1906 was passed after Upton Sinclair published The 06:40.427 --> 06:44.327 Jungle, that described filthy 06:44.331 --> 06:46.751 slaughtering conditions in Chicago. 06:46.750 --> 06:51.630 The Pure Food and Drug Act was passed in 1906 as well, 06:51.629 --> 06:54.749 and it forbade foreign and interstate commerce and 06:54.752 --> 06:58.132 adulterated or fraudulently labeled food and drugs. 06:58.129 --> 07:01.349 So products could now be seized and condemned, 07:01.350 --> 07:03.690 and offending persons could be fined or jailed, 07:03.689 --> 07:06.259 and fresh, canned, or frozen food shipped in 07:06.259 --> 07:09.189 interstate commerce must be pure and wholesome. 07:09.189 --> 07:11.269 That was the new standard back in 1906. 07:11.269 --> 07:14.539 So basically, the idea of adulteration and 07:14.540 --> 07:18.610 the idea of fraudulent labeling became important. 07:18.610 --> 07:23.450 So the very first attempts to try to control risk in society 07:23.452 --> 07:28.542 related to food and agriculture really concentrated on the idea 07:28.543 --> 07:31.793 of labeling, the idea of making sure that 07:31.786 --> 07:35.676 the product inside the package was what it claimed to be and 07:35.680 --> 07:39.310 that it had an effectiveness that was also claimed, 07:39.310 --> 07:41.990 and that it wasn't excessively dangerous. 07:41.990 --> 07:45.530 They really worried about farmers buying pesticides, 07:45.533 --> 07:49.013 disposing pesticides, and then basically having the 07:49.009 --> 07:51.859 container filled with sugar or flour. 07:51.860 --> 07:53.790 How would they know the difference? 07:53.790 --> 07:56.600 There were many cases of fraudulent manufacturing 07:56.598 --> 08:00.338 practices early in the twentieth century, before this law was put 08:00.341 --> 08:01.221 into place. 08:01.220 --> 08:05.450 Another critical statute that built on this was the 08:05.449 --> 08:09.509 Insecticide Act of 1910 that similarly prohibited 08:09.509 --> 08:15.009 fraudulently labeled pesticides and set standards for purity. 08:15.009 --> 08:18.189 So the idea of ingredient labeling was added to the 08:18.185 --> 08:19.325 Insecticide Act. 08:19.329 --> 08:22.969 And it was designed to protect farmers from dangerous and 08:22.970 --> 08:24.400 impotent pesticides. 08:24.399 --> 08:27.429 If you jump forward, you find that the Federal Food, 08:27.432 --> 08:30.172 Drug, and Cosmetic Act of 1938 is important. 08:30.170 --> 08:35.810 And it became the home for pesticide regulation for many 08:35.807 --> 08:41.547 years until EPA took over that responsibility in 1970. 08:41.548 --> 08:45.608 And the Food and Drug Administration was authorized to 08:45.605 --> 08:49.045 set, in 1938, limits for chemicals in food. 08:49.048 --> 08:53.218 So the recognition that if you sprayed a field of corn and you 08:53.219 --> 08:57.459 harvested the corn and then you sold it in the supermarket that 08:57.456 --> 09:01.506 it might still carry residues, this was beginning to be well 09:01.505 --> 09:03.215 recognized back in the 1930s. 09:03.220 --> 09:07.550 The criteria used to set the tolerances was really quite 09:07.546 --> 09:09.666 interesting at that time. 09:09.668 --> 09:11.558 It wasn't a health-based criterion. 09:11.558 --> 09:14.608 It wasn't an environmentally-based criterion. 09:14.610 --> 09:19.510 It was how much residue should be allowed to remain on the food 09:19.514 --> 09:23.954 product if the chemical is sprayed in the field at a dose 09:23.946 --> 09:27.266 that's effective to get the job done, 09:27.269 --> 09:28.879 in other words, to kill the pest? 09:28.879 --> 09:30.409 So that's kind of interesting. 09:30.408 --> 09:34.298 So it was really a standard that was set to make sure that 09:34.304 --> 09:38.414 the residues would not cause the food to be pulled out of the 09:38.405 --> 09:41.545 marketplace because they were adulterated. 09:41.548 --> 09:44.948 So they were really designed to protect the farmer and the 09:44.950 --> 09:48.330 economic value of the crop, rather than the health of the 09:48.326 --> 09:50.566 population or the environmental quality. 09:50.570 --> 09:55.370 The Miller Amendment of 1954 required tolerances for all 09:55.369 --> 09:59.819 pesticides if they might remain as food residues. 09:59.820 --> 10:04.240 And then the Delaney Amendment in 1958 became infamous, 10:04.240 --> 10:08.410 because it set a zero risk standard, a tolerance for 10:08.414 --> 10:10.384 carcinogens in food. 10:10.379 --> 10:15.389 So the exact language is that if a pesticide or other food 10:15.394 --> 10:20.944 additive is carcinogenic in laboratory animals or in humans, 10:20.940 --> 10:24.400 and that was the first time in law that using evidence from 10:24.399 --> 10:27.499 laboratory animals was considered to be sufficient in 10:27.503 --> 10:29.833 order to ban the use of a chemical. 10:29.830 --> 10:34.130 Then it could not be used in a way that would cause the residue 10:34.130 --> 10:36.560 to be present in the food supply. 10:36.558 --> 10:41.188 Now, you can imagine that these chemicals were applied to many 10:41.192 --> 10:42.562 different crops. 10:42.558 --> 10:47.028 And I mentioned to you that DDT in my last lecture was applied 10:47.033 --> 10:50.043 so heavily to so many different foods, 10:50.038 --> 10:54.298 300 different food crops had tolerances by the mid-1950s. 10:54.298 --> 10:58.398 But the government's ability to detect these chemicals is really 10:58.398 --> 11:00.088 important to this story. 11:00.090 --> 11:03.010 So if you use insensitive detection technology, 11:03.009 --> 11:07.099 in other words, supposing that your chemical 11:07.104 --> 11:12.534 detection equipment is only capable of finding residues at 11:12.532 --> 11:17.602 the part per 100,000 level, ten to the minus fifth, 11:17.604 --> 11:20.424 or even part per million level. 11:20.418 --> 11:23.658 And the chemical is there, but it's there at the high part 11:23.663 --> 11:26.483 per billion level, the chemical test is going to 11:26.477 --> 11:28.817 come back negative, it's going to come back as a 11:28.817 --> 11:29.317 non-detect. 11:29.320 --> 11:32.410 So gradually, you see this very interesting 11:32.409 --> 11:36.529 evolution in the concept of purity and what constitutes a 11:36.530 --> 11:40.580 safe and pure environment that's very much driven by the 11:40.577 --> 11:43.887 sensitivity of the detection equipment. 11:43.889 --> 11:48.079 So during the century as the detection equipment became more 11:48.077 --> 11:49.567 and more sensitive. 11:49.570 --> 11:52.650 Now for some dioxins, we can detect those down to the 11:52.650 --> 11:54.370 part per quadrillion level. 11:54.370 --> 11:58.330 And many chemicals are present in food at the part per trillion 11:58.328 --> 11:58.838 level. 11:58.840 --> 12:02.140 It's got people thinking about well, what does that mean? 12:02.139 --> 12:06.049 What does that mean to their potential to influence human 12:06.051 --> 12:06.681 health? 12:06.678 --> 12:10.098 So back in the '40s and '50s, the detection technology was 12:10.100 --> 12:13.040 really quite limited, and also the sampling was quite 12:13.043 --> 12:14.803 limited, so that they really weren't 12:14.802 --> 12:16.032 sampling that many foods. 12:16.028 --> 12:19.478 You can imagine the scale of the problem this presents today, 12:19.477 --> 12:22.637 given the international character of our food supply. 12:22.639 --> 12:25.789 I ask this question with respect to several commodities, 12:25.788 --> 12:29.608 first I started with apples and wondered how many times the 12:29.605 --> 12:32.365 government tested apples for pesticides. 12:32.370 --> 12:34.120 And then I looked at bananas. 12:34.120 --> 12:36.740 And for bananas, for a chemical that was, 12:36.740 --> 12:38.450 when I looked about eight years ago, 12:38.450 --> 12:42.530 one of the most heavily used insecticides on bananas grown in 12:42.529 --> 12:46.019 the tropics, the government was looking at 12:46.023 --> 12:50.463 about fifteen to eighteen samples of bananas for this 12:50.458 --> 12:55.828 compound when I then was able to calculate that several trillion 12:55.831 --> 13:00.781 individual bananas had been imported into the nation during 13:00.778 --> 13:02.228 that year. 13:02.230 --> 13:05.710 So one needs to think about what standards are in place in 13:05.714 --> 13:09.624 different parts of the world, where that food is likely to 13:09.621 --> 13:12.621 go, keeping records of import statistics, 13:12.620 --> 13:16.040 and then think about what kind of a sampling design would be 13:16.044 --> 13:19.534 necessary in order to find these residues in a way that might 13:19.528 --> 13:21.908 eventually lead to health protection. 13:21.908 --> 13:25.428 So the Delaney Amendment was really quite striking. 13:25.428 --> 13:30.458 It was adopted really with great support in Congress, 13:30.456 --> 13:33.256 in part because of the U.S. 13:33.259 --> 13:35.869 fascination with cancer and also cancer management. 13:35.870 --> 13:40.010 So this grew in part because of the nuclear weapons testing era, 13:40.009 --> 13:43.739 but it is curious that within the European nations, 13:43.740 --> 13:47.210 the regulatory approach to environmental quality has not 13:47.207 --> 13:50.707 been as concerned with cancer, it's been more concerned with 13:50.706 --> 13:53.196 neurological decline and also reproductive health. 13:53.200 --> 13:55.850 So it raises really interesting questions about why the 13:55.851 --> 13:58.261 preoccupation in the United States with cancer. 13:58.259 --> 14:02.049 So the first seriously health protective statute that we can 14:02.051 --> 14:05.971 find in environmental law has to do with food and it has to do 14:05.970 --> 14:08.740 with pesticides, and it's contained in this 14:08.735 --> 14:09.765 Delaney Amendment. 14:09.769 --> 14:12.399 By the way, this amendment applies to all food additives. 14:12.399 --> 14:15.629 And a food additive could be defined also as a coloring 14:15.634 --> 14:18.334 agent, like the salmon coloring I spoke of. 14:18.330 --> 14:22.110 It could be defined as a packaging material migrant. 14:22.110 --> 14:26.330 It could be a flavoring agent as well, so that the standard is 14:26.330 --> 14:27.230 very clear. 14:27.230 --> 14:30.830 If it induces cancer in animals or in humans, 14:30.831 --> 14:32.881 then it is not allowed. 14:32.879 --> 14:37.379 Curiously, there is a clause within the statute that applies 14:37.376 --> 14:41.566 only to pesticides that are defined as food additives if 14:41.568 --> 14:43.168 they concentrate. 14:43.168 --> 14:46.188 And you remember the story I told you the other day about 14:46.187 --> 14:49.257 taking a grape and extracting all the water out of it, 14:49.259 --> 14:52.809 or taking corn and extracting the oil out of it, 14:52.808 --> 14:56.098 and having to be thoughtful about what that really might 14:56.096 --> 14:57.826 mean for chemical residues. 14:57.830 --> 15:01.210 So if you are concerned about oil extraction, 15:01.207 --> 15:04.277 you need to think about lipophilicity. 15:04.278 --> 15:07.928 So if you've got a chemical such as a chlorinated carbon 15:07.932 --> 15:11.852 that is likely to bind onto fats of one form or another, 15:11.850 --> 15:15.540 extracting the oil out will likely also concentrate the 15:15.541 --> 15:16.841 chemical residue. 15:16.840 --> 15:19.660 So if you look in the code of federal regulations, 15:19.658 --> 15:20.808 it's very curious. 15:20.808 --> 15:22.968 You can go over to the law library and pull out the code of 15:22.969 --> 15:24.309 federal regulations on pesticides. 15:24.308 --> 15:27.818 Actually, it would be a good assignment for teaching fellows 15:27.817 --> 15:28.827 to disseminate. 15:28.830 --> 15:34.310 Go look at the code of federal regulations for pesticide 15:34.312 --> 15:38.202 residues in food, and you'll see 40 CFR, 15:38.202 --> 15:39.002 135. 15:39.000 --> 15:42.190 And you go to the appendix, and the appendix is several 15:42.188 --> 15:45.908 hundred pages long of individual pesticide-food combinations. 15:45.908 --> 15:50.028 So I was quite struck by his several years ago. 15:50.029 --> 15:52.839 And I added all of these up and it turns out that there are 15:52.835 --> 15:55.395 about 10,000 different pesticide-food combinations. 15:55.399 --> 16:00.879 And if you look carefully at these combinations that set 16:00.875 --> 16:06.645 limits for benomyl in bananas or let's say chlorpyriphos in 16:06.650 --> 16:11.030 apples or DDT in milk, that standard is still in place 16:11.033 --> 16:11.693 by the way. 16:11.690 --> 16:14.440 It's kind of interesting, even though DDT was banned, 16:14.436 --> 16:16.546 as I said the other day, in the 1970s. 16:16.548 --> 16:19.618 But if you look carefully, you'll see that you get a 16:19.620 --> 16:23.300 different residue limit allowed for fresh corn or fresh apples 16:23.296 --> 16:26.906 or fresh soybeans than you do for the processed product. 16:26.908 --> 16:29.878 And it's basically because of this concentration factor. 16:29.879 --> 16:33.539 So water extraction, making raisins out of grapes, 16:33.543 --> 16:37.803 making wine out of grapes, or making oils out of different 16:37.803 --> 16:40.873 kinds of grains can have this effect. 16:40.870 --> 16:45.990 The Federal Insecticide, Fungicide, and Rodenticide Act 16:45.994 --> 16:50.454 of 1947 was the central statute that was passed, 16:50.453 --> 16:54.633 and it really set the stage for the U.S. 16:54.629 --> 16:58.689 Department of Agriculture's authority to issues licenses or 16:58.690 --> 16:59.810 registrations. 16:59.808 --> 17:03.138 So as I mentioned earlier, the idea of registering a 17:03.140 --> 17:06.930 pesticide or allowing it to be used for a certain crop, 17:06.930 --> 17:10.350 these registrations were given out one after another after 17:10.348 --> 17:12.738 another, decade after decade, 17:12.736 --> 17:16.196 so that by 1960, there were 50,000 different 17:16.201 --> 17:19.461 pesticide registrations that had been issued. 17:19.460 --> 17:21.910 And by 1970, there were nearly 70,000 17:21.910 --> 17:23.680 pesticide registrations. 17:23.680 --> 17:26.760 And a registration is given for a specific chemical use, 17:26.755 --> 17:29.715 and it may be also assigned for a specific package. 17:29.720 --> 17:36.890 So you may have chemical X, and that has one registration. 17:36.890 --> 17:39.730 And then it may be sold also with chemical Y or chemical Y 17:39.726 --> 17:42.606 and Z, and they would have different registrations assigned 17:42.612 --> 17:43.062 them. 17:43.058 --> 17:46.078 And they might have different registrations assigned for 17:46.078 --> 17:48.928 different kinds of uses, so that these chemicals were 17:48.932 --> 17:51.022 not just used on food commodities. 17:51.019 --> 17:53.659 Where else might they be used? 17:53.660 --> 17:55.500 Well, think about it. 17:55.500 --> 17:59.620 Many of the buildings at Yale are sprayed by pesticides 17:59.616 --> 18:00.376 indoors. 18:00.380 --> 18:03.840 So that type of use often had to have a separate registration. 18:03.838 --> 18:06.358 Sprayed in subways, sprayed in vehicles, 18:06.358 --> 18:11.468 added to materials such as plastics that are components of 18:11.467 --> 18:15.407 cars or that are components of urethanes, 18:15.410 --> 18:17.050 for example, that coat the wood here. 18:17.048 --> 18:21.678 So that plastics have carried biocides into our environment in 18:21.680 --> 18:23.350 a whole set of ways. 18:23.348 --> 18:26.918 And the government had to keep track of where these chemicals 18:26.924 --> 18:30.744 were going, and had to license each of these distinctive uses. 18:30.740 --> 18:35.380 So the FIFRA of 1947 was important because it defined 18:35.380 --> 18:38.860 these chemicals as economic poisons, 18:38.858 --> 18:40.948 implying yes, they're poisonous, 18:40.950 --> 18:45.130 but they also carry an economic benefit so that we need to look 18:45.132 --> 18:48.642 at this using a utilitarian balancing standard, 18:48.640 --> 18:53.610 so that risk-benefit balancing became the phrase that guided 18:53.605 --> 18:54.105 U.S. 18:54.108 --> 18:58.658 Department of Agriculture to crank out these registrations. 18:58.660 --> 19:03.000 It also extended the regulations, not just to 19:02.999 --> 19:06.349 insecticides, but to herbicides and 19:06.353 --> 19:08.033 rodenticides. 19:08.028 --> 19:10.278 And right now, in terms of volume of chemical 19:10.278 --> 19:12.988 released in the world, you find the herbicides are the 19:12.990 --> 19:14.780 most heavily type of pesticide. 19:14.778 --> 19:18.828 So there are pesticides, there are insecticides, 19:18.828 --> 19:23.368 herbicides, rodenticides designed to kill rats or mice, 19:23.368 --> 19:27.968 slimicides, that are applied to kill slime and algae on the side 19:27.969 --> 19:30.889 of nuclear power plant cooling towers. 19:30.890 --> 19:34.150 There are nearly a hundred different chemicals. 19:34.150 --> 19:35.820 Any swimmers in the room? 19:35.818 --> 19:38.808 Probably a few, or former swimmers? 19:38.808 --> 19:41.378 Well, there are nearly a hundred different pesticides 19:41.375 --> 19:44.335 that have been registered for use in swimming pools to kill a 19:44.335 --> 19:48.825 variety of viruses, bacteria, as well as molds and 19:48.832 --> 19:50.712 other pathogens. 19:50.710 --> 19:54.490 If you think about that carefully and you think about 19:54.487 --> 19:58.257 the relative risk that is associated with using those 19:58.263 --> 20:01.463 chemicals as opposed to not using them, 20:01.460 --> 20:03.130 it's probably a really good choice, 20:03.130 --> 20:07.390 given the illnesses that could live in that environment. 20:07.390 --> 20:11.710 So that this statute was the first to really break down these 20:11.705 --> 20:15.945 different categories of biocides and really assign different 20:15.951 --> 20:18.111 regulatory responsibility. 20:18.108 --> 20:21.308 No authority was given to the Department of Agriculture, 20:21.310 --> 20:24.920 however, to remove hazardous chemicals from the marketplace. 20:24.920 --> 20:27.940 So that they always found that the benefits outweighed the 20:27.939 --> 20:28.309 risk. 20:28.308 --> 20:32.548 There are no instances that I can point to that the Department 20:32.554 --> 20:36.804 of Agriculture either banned a chemical or found that the risk 20:36.798 --> 20:38.188 was too serious. 20:38.190 --> 20:41.340 They may have adjusted the allowable use rates or the type 20:41.338 --> 20:44.708 of environment it could be released to or the type of crop. 20:44.710 --> 20:46.740 But no product bans. 20:46.740 --> 20:48.190 And think about this. 20:48.190 --> 20:50.460 The government gave, the Congress gave the 20:50.457 --> 20:53.387 Department of Agriculture the authority to manage this 20:53.387 --> 20:55.487 program, to implement the program. 20:55.490 --> 20:57.540 Now, is that a good idea? 20:57.538 --> 21:00.018 What's the Department of Agriculture's basic role? 21:00.019 --> 21:03.629 Well, it's really to promote economic production of a variety 21:03.632 --> 21:06.042 of different agricultural commodities. 21:06.038 --> 21:10.018 And they really also do not have and have not had much 21:10.017 --> 21:14.367 expertise in environmental science to know what happened to 21:14.369 --> 21:18.719 the chemicals once they were released or to think carefully 21:18.722 --> 21:21.052 about the health effects. 21:21.048 --> 21:24.808 So the medical expertise within the Department of Agriculture 21:24.813 --> 21:27.513 throughout their period of jurisdiction, 21:27.509 --> 21:30.469 which ended in 1970, when the Environmental 21:30.471 --> 21:34.511 Protection Agency was formed, was a period when they really 21:34.510 --> 21:37.890 had very little expertise in environmental science or in 21:37.891 --> 21:40.891 medical science, which is really fundamental to 21:40.894 --> 21:44.094 the way that we're thinking about regulating pesticides 21:44.086 --> 21:44.616 today. 21:44.618 --> 21:48.438 The FIFRA amendments in 1964 came after Rachel Carson's book, 21:48.440 --> 21:51.510 Silent Spring, raised the alarm and caused the 21:51.511 --> 21:54.881 population to be quite upset about pesticide residues, 21:54.880 --> 21:57.160 particularly their effect on wildlife, 21:57.160 --> 22:01.640 but also growing recognition that these chemicals could build 22:01.644 --> 22:03.144 in the human body. 22:03.140 --> 22:07.460 And also the Food and Drug Administration's admission that 22:07.459 --> 22:11.779 they had found pesticides in human breast milk as early as 22:11.778 --> 22:12.458 1952. 22:12.460 --> 22:16.930 The public wasn't warned about this. 22:16.930 --> 22:20.880 And basically, if you find a chemical, 22:20.880 --> 22:24.660 regardless of what it is, you find it in another species 22:24.662 --> 22:27.552 of mammal's breast milk, you can presume that it's 22:27.550 --> 22:29.450 likely to get into human breast milk as well. 22:29.450 --> 22:32.690 So Rachel Carson's Silent Spring turned out to be a 22:32.694 --> 22:35.404 real watershed, not just legally for 22:35.400 --> 22:39.690 pesticides, because it really increased the sense of 22:39.686 --> 22:44.306 susceptibility to biocides or the economic poisons, 22:44.308 --> 22:49.048 but it really met with quite a bit of resistance in Congress. 22:49.048 --> 22:53.838 Again, this was the end of the nuclear weapons testing era in 22:53.842 --> 22:55.202 the atmosphere. 22:55.200 --> 22:58.720 And it was also a period of great unrest in the United 22:58.721 --> 22:59.321 States. 22:59.318 --> 23:04.688 The origin of the Civil Rights Movement may be traced to this 23:04.692 --> 23:05.502 period. 23:05.500 --> 23:09.050 The Civil Rights Act of 1964, recall that. 23:09.048 --> 23:12.028 Also, we were getting more deeply embedded in the war in 23:12.027 --> 23:13.757 Vietnam at that point in time. 23:13.759 --> 23:18.089 And environmentalism was growing up, creeping up on the 23:18.087 --> 23:18.807 agenda. 23:18.808 --> 23:21.158 But it was really quite an interesting period. 23:21.160 --> 23:23.430 Congress, however, was preoccupied. 23:23.430 --> 23:27.280 Other than making some minor revisions to the statute that 23:27.284 --> 23:29.994 included adding these words: caution, 23:29.990 --> 23:32.320 warning, and hazard, depending upon the relative 23:32.323 --> 23:32.873 toxicity. 23:32.868 --> 23:35.928 This didn't really help very much because of public confusion 23:35.928 --> 23:37.608 about what those phrases meant. 23:37.608 --> 23:40.788 And the Department of Agriculture's secretary was 23:40.788 --> 23:44.228 given authority finally to remove pesticides from the 23:44.230 --> 23:48.270 market based upon a finding of imminent hazard to public. 23:48.269 --> 23:51.749 Now, EPA was created in 1970, and it was given the 23:51.748 --> 23:54.938 responsibility to manage pesticides and it was 23:54.942 --> 23:57.572 consolidated from other agencies. 23:57.568 --> 24:01.228 Some fifteen or sixteen different subunits of different 24:01.230 --> 24:05.300 agencies were pulled together to create EPA back in 1970, 24:05.298 --> 24:07.318 including the Department of Agriculture, 24:07.318 --> 24:10.078 that had formerly had the pesticide management 24:10.077 --> 24:11.117 responsibility. 24:11.118 --> 24:16.448 So you can imagine entire sub-bureaucracies picking up and 24:16.453 --> 24:19.453 moving their materials to EPA. 24:19.450 --> 24:22.910 And the stories from some of the early administrators about 24:22.911 --> 24:26.311 how they did this and what the effect was are really quite 24:26.314 --> 24:27.094 striking. 24:27.088 --> 24:30.068 They described that the Department of Agriculture had 24:30.065 --> 24:32.235 kept files on individual chemicals, 24:32.240 --> 24:34.010 but they were completely disorganized, 24:34.009 --> 24:37.119 often just handwritten, often with no environmental 24:37.123 --> 24:40.213 science data, often no testing of chemical 24:40.207 --> 24:43.857 presence in different commodities that it had been 24:43.861 --> 24:45.801 licensed to be used on. 24:45.798 --> 24:49.538 And some chemicals had no data at all. 24:49.538 --> 24:54.088 So EPA was in this situation of becoming immediately responsible 24:54.086 --> 24:57.476 for 70,000 different pesticide registrations. 24:57.480 --> 25:01.040 The public was quite concerned about these residues getting 25:01.040 --> 25:04.600 into their bodies and into the environment and the wildlife 25:04.603 --> 25:05.343 effects. 25:05.339 --> 25:07.099 So they felt a lot of heat. 25:07.098 --> 25:09.698 Increasingly, environmental laws had these 25:09.703 --> 25:13.343 citizen suit provisions, so EPA was getting sued in the 25:13.342 --> 25:16.272 early 1970s, and they got sued on a variety 25:16.266 --> 25:19.046 of compounds, such as DDT and aldrin and 25:19.048 --> 25:19.728 dieldrin. 25:19.730 --> 25:22.990 And they were forced to go back and look at the data that they 25:22.990 --> 25:25.710 had available, and they found that they really 25:25.709 --> 25:29.269 had very little data to justify many of these registrations. 25:29.269 --> 25:33.439 But the law was set up that forced them to look at this 25:33.442 --> 25:35.842 problem a chemical at a time. 25:35.838 --> 25:38.328 So if you've got 70,000 different chemicals, 25:38.328 --> 25:41.648 and the law requires that you look at them one at a time and 25:41.648 --> 25:45.248 you've got a staff that doesn't have the basic data in place, 25:45.250 --> 25:48.530 this basically put the regulatory process in deep 25:48.525 --> 25:49.135 freeze. 25:49.140 --> 25:53.500 So how would you manage that if you were responsible? 25:53.500 --> 25:56.590 Well, Congress thought about this, and they allocated more 25:56.586 --> 25:59.616 and more money to the Environmental Protection Agency. 25:59.618 --> 26:02.308 And EPA became much more aggressive and starting banning 26:02.311 --> 26:02.901 chemicals. 26:02.900 --> 26:06.430 They banned DDT first and then aldrin and then dieldrin, 26:06.432 --> 26:08.492 heptachlor and then chlordane. 26:08.490 --> 26:10.560 All of these were the chlorinated hydrocarbons. 26:10.558 --> 26:14.448 The FIFRA amendments of 1975 gave the Secretary of 26:14.453 --> 26:18.113 Agriculture authority to be notified of pending 26:18.108 --> 26:21.718 cancellations, which meant that he was given a 26:21.720 --> 26:23.820 voice to oppose cancellations. 26:23.818 --> 26:27.678 But the Environmental Protection Agency really became 26:27.676 --> 26:31.906 the stewards for human health and environmental quality so 26:31.905 --> 26:35.165 that the Secretary of Agriculture's voice was 26:35.170 --> 26:37.470 diminishing in the 1970s. 26:37.470 --> 26:41.100 Congress also recognized that EPA's not making much progress 26:41.097 --> 26:44.417 on this sea of chemicals, so they'd better do something 26:44.420 --> 26:45.220 about it. 26:45.220 --> 26:48.540 They mandated that each chemical had to be reviewed 26:48.538 --> 26:50.528 within a nine-year deadline. 26:50.529 --> 26:53.989 Well, EPA was not able to accomplish that, 26:53.990 --> 26:57.660 so the '70s and the '80s and '90s were all great examples of 26:57.663 --> 27:01.523 what I call the rule of twenty, that each chemical might get 27:01.517 --> 27:03.687 some attention every twenty years. 27:03.690 --> 27:05.240 But what does that mean? 27:05.240 --> 27:07.740 You can think about the fact that new chemicals are being 27:07.740 --> 27:10.570 added to the marketplace, new registrations are being 27:10.565 --> 27:13.305 issued, the data are lousy and EPA is 27:13.314 --> 27:17.154 taking twenty years to review a single chemical, 27:17.150 --> 27:18.520 that doesn't make sense. 27:18.519 --> 27:21.719 The science is evolving at a lightening pace on where the 27:21.720 --> 27:25.550 chemicals are in the environment or what the health effects are, 27:25.548 --> 27:28.248 or what the effects on different species are. 27:28.250 --> 27:33.370 And EPA is like this ship that is frozen, it's icebound, 27:33.365 --> 27:38.475 unable to move with a speed that it really needed to. 27:38.480 --> 27:41.000 Well, this was recognized by the National Academy of 27:40.997 --> 27:43.497 Sciences, in two publications that I had 27:43.499 --> 27:46.869 a chance to work on, one regulating pesticides and 27:46.868 --> 27:50.128 food that really critiqued the Delaney paradox. 27:50.130 --> 27:54.000 And a bunch of us thought that the zero risk standard as it had 27:53.996 --> 27:57.856 been interpreted by the Food and Drug Administration really did 27:57.863 --> 27:59.363 not make much sense. 27:59.358 --> 28:04.278 FDA had interpreted zero risk to mean a little bit of risk. 28:04.278 --> 28:07.178 So de minimis is the phrase that it used. 28:07.180 --> 28:11.770 And de minimis means a trivial amount of risk. 28:11.769 --> 28:14.769 And they define that generally as a one-in-a-million risk 28:14.767 --> 28:15.407 threshold. 28:15.410 --> 28:19.780 So that this was a curious experience for me, 28:19.777 --> 28:24.937 because it was my first exploration of the human diet 28:24.938 --> 28:27.318 and its variability. 28:27.318 --> 28:31.698 So I started poring through food intake surveys, 28:31.700 --> 28:34.560 which is the reason that I asked a section on Monday night 28:34.555 --> 28:37.005 to keep track of just one day of your own diet. 28:37.009 --> 28:40.019 Think about that, what foods do you eat, 28:40.019 --> 28:43.759 as a way of thinking about how patterns in your diet might lead 28:43.763 --> 28:47.393 to predictable patterns of your exposure to residues that had 28:47.386 --> 28:49.256 been allowed by government. 28:49.259 --> 28:52.469 So in this case, we were looking only at that 28:52.465 --> 28:55.665 subset of chemicals that had some evidence of 28:55.672 --> 28:57.132 carcinogenicity. 28:57.130 --> 29:00.750 So that these chemicals induced cancer in animals or were known 29:00.753 --> 29:02.453 to induce cancer in humans. 29:02.450 --> 29:05.920 And we were thinking particularly about how cancer 29:05.923 --> 29:08.833 risk might add up across the chemicals. 29:08.828 --> 29:11.918 So a hundred different chemicals that are cancer 29:11.920 --> 29:15.400 inducing in laboratory experiments, how would you deal 29:15.404 --> 29:17.974 with that issue of risk additivity? 29:17.970 --> 29:23.360 Would it be possible that there may be a negative effect on risk 29:23.356 --> 29:27.886 if you had two chemical exposures at the same time? 29:27.890 --> 29:31.230 Well, scientists have found some cases where that actually 29:31.227 --> 29:33.817 occurred, where a lower risk chemical is 29:33.817 --> 29:37.527 able to bind onto a site in a cell and prevent a higher risk 29:37.529 --> 29:39.919 chemical from doing the same thing. 29:39.920 --> 29:42.030 In other cases, there's a synergistic 29:42.030 --> 29:45.590 relationship, so that the risk is not just 29:45.589 --> 29:48.019 additive, but if you're exposed to 29:48.021 --> 29:51.221 chemical A and then chemical B, you've got a higher risk of 29:51.223 --> 29:51.983 getting cancer. 29:51.980 --> 29:56.220 So working with a bunch of specialists in cancer, 29:56.220 --> 29:59.790 as well as specialists in residue chemistry and exposure 29:59.789 --> 30:02.409 analysis, we came up with a not too 30:02.413 --> 30:06.403 complimentary picture of the way that EPA had regulated 30:06.397 --> 30:10.597 carcinogens in the food and recommended also that they pay 30:10.604 --> 30:14.224 much more attention to the individual diet, 30:14.220 --> 30:18.680 that the diet was likely to be the key route of exposure to a 30:18.683 --> 30:21.143 variety of different chemicals. 30:21.140 --> 30:24.420 The second book flowed from the first by the National Academy of 30:24.417 --> 30:27.377 Sciences, called Pesticides in the Diets of Infants and 30:27.384 --> 30:28.274 Children. 30:28.269 --> 30:31.789 And this focused on a finding inside the red book, 30:31.788 --> 30:35.368 the finding that there's a lot of variability out there in the 30:35.366 --> 30:38.296 diets that people eat that is quite predictable. 30:38.298 --> 30:40.918 So if you're Italian, you're likely to eat more 30:40.915 --> 30:41.935 tomato products. 30:41.940 --> 30:44.540 If you're Latino, you're likely to eat more corn 30:44.540 --> 30:45.150 products. 30:45.150 --> 30:49.700 If you are an African American from the southern part of the 30:49.695 --> 30:52.695 United States, people generally eat more 30:52.702 --> 30:53.552 greens. 30:53.548 --> 30:56.408 If you are living in California, you're going to eat 30:56.412 --> 30:59.272 more fresh produce than you would if you live in the 30:59.273 --> 31:00.063 Northeast. 31:00.058 --> 31:04.608 Its cost does not go up the way that it does in the Northeast. 31:04.608 --> 31:08.948 So diet varied by season, it varied by region of the 31:08.949 --> 31:13.709 country, it varies by age, and it also varies quite a bit 31:13.712 --> 31:15.162 by ethnicity. 31:15.160 --> 31:17.300 So if you don't understand these differences in dietary 31:17.295 --> 31:19.615 patterns, you really don't have much hope 31:19.623 --> 31:23.153 of understanding the variability in the chemical matrix that 31:23.151 --> 31:26.381 these individual diets might convey into your body. 31:26.380 --> 31:30.530 So it also presents a really kind of an interesting idea that 31:30.530 --> 31:34.610 you could use cropping patterns as a way of predicting which 31:34.614 --> 31:38.424 chemicals make their way into certain environments. 31:38.420 --> 31:42.060 So if you were looking at the effect of corn on environmental 31:42.058 --> 31:44.798 quality in the United States, corn production, 31:44.797 --> 31:46.987 you would want to know where it is planted. 31:46.990 --> 31:50.800 Predominantly in the Midwestern part of the U.S., 31:50.804 --> 31:55.894 ground zero is pretty much Iowa through Ohio and Pennsylvania. 31:55.890 --> 32:00.110 And if you map out the pattern of chemical use, 32:00.108 --> 32:03.248 you'll see that herbicides are applied much more intensely in 32:03.250 --> 32:05.660 this area than in other parts of the nation. 32:05.660 --> 32:10.070 And that explains why herbicide residues are detectable in the 32:10.073 --> 32:14.053 water supplies of nearly 30 million people in the United 32:14.051 --> 32:16.731 States and also in human tissues. 32:16.730 --> 32:20.460 So that this understanding of dietary diversity turned out to 32:20.463 --> 32:24.323 be extremely important because it had been completely neglected 32:24.323 --> 32:25.883 by environmental law. 32:25.880 --> 32:29.970 And the diversity in patterns of exposure in environmental law 32:29.967 --> 32:33.847 is something that I became curious about and wondered about 32:33.854 --> 32:37.884 whether or not you'd find the same thing relative to drinking 32:37.875 --> 32:38.675 water. 32:38.680 --> 32:42.260 Would you find the same issue relative to air quality? 32:42.259 --> 32:45.329 Are there pockets of high exposure out there in the 32:45.329 --> 32:48.459 population that could be predictable that would make 32:48.461 --> 32:52.331 environmental law and regulation able to focus in a way that was 32:52.329 --> 32:53.619 more effective? 32:53.619 --> 32:55.519 And the answer is yes. 32:55.519 --> 32:59.129 So as we look across cases over the next couple of weeks, 32:59.130 --> 33:01.910 we'll see the same pattern emerging, 33:01.910 --> 33:04.160 that once you understand variability in the diet, 33:04.160 --> 33:07.950 in other words, once you focus in and you look 33:07.951 --> 33:12.471 for pockets of high exposure, high consumption of corn or 33:12.468 --> 33:15.698 high consumption of a certain cluster of foods. 33:15.700 --> 33:18.020 Or you look at certain populations, 33:18.019 --> 33:21.109 such as athletes, that have a higher respiration 33:21.105 --> 33:25.135 rate than non-athletes do, that because of that higher 33:25.140 --> 33:28.110 respiration rate, they're going to absorb more 33:28.111 --> 33:30.161 chemicals that are present in the air. 33:30.160 --> 33:33.630 So across a whole array of different kinds of environmental 33:33.633 --> 33:35.793 problems that are managed by law, 33:35.788 --> 33:38.618 there's basically, there had been neglect of this 33:38.622 --> 33:39.982 issue of variability. 33:39.980 --> 33:43.710 So how do you take a body of law such as the body that I just 33:43.711 --> 33:46.201 described to you for these chemicals, 33:46.200 --> 33:49.780 and transform it to be more sensitive to the reality of 33:49.779 --> 33:52.829 these patterns of chemical use and exposure? 33:52.828 --> 33:56.468 So what I'm painting here is a picture of what I think of as 33:56.465 --> 33:58.865 fractured science and fractured law, 33:58.868 --> 34:02.578 so that the legal authority for pesticides is now broken into 34:02.579 --> 34:05.469 three different bureaus, the Environmental Protection 34:05.468 --> 34:07.058 Agency, that is responsible for 34:07.057 --> 34:10.057 tolerance setting, but also toxicity testing. 34:10.059 --> 34:12.539 The Food and Drug Administration is responsible 34:12.538 --> 34:14.908 for detecting residues in the food supply. 34:14.909 --> 34:17.509 And the Department of Agriculture is responsible for 34:17.507 --> 34:20.407 the enforcement of these statutes in meat and poultry, 34:20.409 --> 34:25.009 and also for the assessment of economic benefits associated 34:25.014 --> 34:28.354 with producing the nation's food supply. 34:28.349 --> 34:30.629 So you've got these different agencies with different legal 34:30.632 --> 34:32.722 mandates, and they tend not to talk to one another. 34:32.719 --> 34:36.319 So that in Great Britain, they've created a new food 34:36.320 --> 34:40.270 safety organization that is really quite distinctive as a 34:40.273 --> 34:40.983 model. 34:40.980 --> 34:43.750 They had the same fractured pattern of bureaucratic control 34:43.748 --> 34:45.798 in Great Britain, and they decided that they 34:45.800 --> 34:47.090 would consolidate that. 34:47.090 --> 34:49.210 They'd centralize the authority in one group. 34:49.210 --> 34:52.310 And it's very curious, because by doing that, 34:52.309 --> 34:55.959 it has allowed conservative administrations to slow down 34:55.956 --> 34:59.866 regulation and to become less environmentally protected much 34:59.869 --> 35:03.249 more quickly than if the authority is diffused among 35:03.251 --> 35:04.911 different agencies. 35:04.909 --> 35:07.059 So this is a very interesting kind of a problem. 35:07.059 --> 35:10.309 The primary authority for tolerance setting was taken away 35:10.311 --> 35:12.481 from the Department of Agriculture, 35:12.480 --> 35:16.580 just like the authority for regulating nuclear power was 35:16.579 --> 35:20.159 taken away from the Atomic Energy Commission, 35:20.159 --> 35:23.339 so the Nuclear Regulatory Commission was created. 35:23.340 --> 35:26.900 So you don't want the producer and the protector of the public 35:26.896 --> 35:29.866 interest to be sitting inside the same organization, 35:29.869 --> 35:31.969 that's really the key principle. 35:31.969 --> 35:39.159 For those of you that I haven't stunned to death enough with 35:39.164 --> 35:43.634 this lecture so far, if you want to know more about 35:43.630 --> 35:45.790 pesticide science and history in law, 35:45.789 --> 35:48.509 I published this book about ten years ago, 35:48.510 --> 35:52.570 and this really details the description of how we discovered 35:52.572 --> 35:56.702 that kids were more exposed to many different pesticides than 35:56.702 --> 36:00.672 adults, that was eventually adopted 36:00.666 --> 36:05.196 into the Food Quality Protection Act, 36:05.199 --> 36:06.579 passed in 1996. 36:06.579 --> 36:10.159 So that this law was designed to deal with this problem of 36:10.157 --> 36:13.167 risk being not equally distributed in society. 36:13.170 --> 36:16.550 And it included a new general safety standard. 36:16.550 --> 36:19.450 It did away with the risk-benefit balancing standard 36:19.447 --> 36:21.487 and it said, "Okay, instead, 36:21.489 --> 36:24.939 EPA must make its choices based upon the phrase 'reasonable 36:24.936 --> 36:28.276 certainty of no harm.'" It's kind of interesting. 36:28.280 --> 36:32.300 If you were given the assignment to include a decision 36:32.302 --> 36:35.952 standard in a statute that was health protective, 36:35.945 --> 36:37.915 what would you choose? 36:37.920 --> 36:39.440 Would you choose a balancing standard? 36:39.440 --> 36:40.880 Probably not. 36:40.880 --> 36:43.070 Would you choose the Delaney clause model, 36:43.070 --> 36:44.780 which is a zero-risk standard? 36:44.780 --> 36:46.930 You might. 36:46.929 --> 36:49.269 Would you choose a standard such as this, 36:49.269 --> 36:51.259 reasonable certainty of no harm? 36:51.260 --> 36:54.620 Well, you can imagine that this was hammered out politically in 36:54.621 --> 36:57.931 Congress with great interest on the part of chemical companies 36:57.927 --> 37:00.957 and also food manufacturers to try to understand what its 37:00.963 --> 37:02.973 implications might be for them. 37:02.969 --> 37:05.559 It also requires a finding of safety. 37:05.559 --> 37:08.609 This had not been part of the law until 1996. 37:08.610 --> 37:14.220 So EPA must now find that chemicals are safe for children. 37:14.219 --> 37:15.949 This is really quite new and striking. 37:15.949 --> 37:19.529 And it requires a tenfold additional safety factor to 37:19.525 --> 37:23.715 account for uncertainty in the data that they have as they set 37:23.719 --> 37:24.889 their limits. 37:24.889 --> 37:29.109 So that this idea of a buffer zone, if you think the risk is 37:29.110 --> 37:33.190 X, then you have to allow X over what in order to set your 37:33.188 --> 37:35.048 standard for exposure? 37:35.050 --> 37:38.060 Well, do you want a tenfold safety factor? 37:38.059 --> 37:41.359 Do you want a hundredfold, a thousand fold? 37:41.360 --> 37:44.190 Well, the tradition had been to use a hundredfold safety factor. 37:44.190 --> 37:47.480 So if you think that this is what it is, you account for your 37:47.478 --> 37:50.438 absence of knowledge or your ignorance, by dividing the 37:50.440 --> 37:52.250 allowable level by a hundred. 37:52.250 --> 37:53.410 And in this case, Congress said, 37:53.405 --> 37:54.555 "That's not good enough. 37:54.559 --> 37:57.339 You a have to divide it by an additional ten to account for 37:57.344 --> 38:00.134 the uncertainty about the distributional patterns." 38:00.130 --> 38:03.770 And also, the issue of some groups being more susceptible to 38:03.768 --> 38:05.618 these chemicals than others. 38:05.619 --> 38:10.309 It also required that the agency for the first time needed 38:10.306 --> 38:15.566 to consider how people might be exposed to the same chemical, 38:15.570 --> 38:21.300 not just from food or different crops, 38:21.300 --> 38:24.810 but food, drinking water, and other kinds of 38:24.806 --> 38:26.026 environments. 38:26.030 --> 38:28.610 So the same chemical might be sprayed on fruits and 38:28.610 --> 38:31.140 vegetables, and it might get into dairy cattle. 38:31.139 --> 38:33.659 But it also might be sprayed in your apartment building. 38:33.659 --> 38:37.389 Or it also might be used as an algaecide in a swimming pool. 38:37.389 --> 38:41.569 So that formerly EPA had just kind of given out licenses as 38:41.572 --> 38:44.892 USDA had to these different allowable uses, 38:44.889 --> 38:48.129 and not thought about the fact that to somebody as they 38:48.132 --> 38:51.742 basically walked through their daily life could be exposed to 38:51.735 --> 38:55.515 the same chemical across these environmental compartments, 38:55.519 --> 38:56.699 so to speak. 38:56.699 --> 38:58.439 So the idea of aggregate risk is new, 38:58.440 --> 39:01.800 and it's an attempt to think about the complexity of the way 39:01.795 --> 39:04.805 that these compounds can move through environments. 39:04.809 --> 39:07.919 The idea of cumulative risk is also new. 39:07.920 --> 39:11.460 That the government had to consider the idea that a group 39:11.463 --> 39:15.073 of chemicals might act the same way in the human body, 39:15.070 --> 39:17.120 and the risk might be at least additive, 39:17.119 --> 39:18.589 if not synergistic. 39:18.590 --> 39:22.630 So for the first time in 1996, EPA had to review all of its 39:22.632 --> 39:25.702 tolerances to think about cumulative risk. 39:25.699 --> 39:29.939 And the pace of review was also sped up so that all chemicals 39:29.943 --> 39:33.483 that it had licensed had to be reviewed by 2006. 39:33.480 --> 39:36.580 That was accomplished, quite remarkably. 39:36.579 --> 39:41.709 But the critique I could give you of the quality of the review 39:41.710 --> 39:43.730 is a different matter. 39:43.730 --> 39:46.250 And finally, Congress directed the agency 39:46.253 --> 39:49.413 not to give equal attention to every pesticide, 39:49.409 --> 39:52.249 but to come through, or to develop some sort of a 39:52.253 --> 39:55.403 strategy to concentrate and focus on chemicals that it 39:55.396 --> 39:57.526 thought would be the most risky. 39:57.530 --> 39:58.820 So how would you do that? 39:58.820 --> 40:01.690 How would you define the most risky chemicals? 40:01.690 --> 40:04.900 Well, you'd try to find those that had the highest 40:04.896 --> 40:06.266 dose-response rate. 40:06.268 --> 40:08.378 In other words, they seemed like they were the 40:08.375 --> 40:09.915 most potent, or the most toxic. 40:09.920 --> 40:12.680 But you'd also probably want to concentrate on chemicals that 40:12.684 --> 40:14.784 were persistent, chemicals that got into 40:14.784 --> 40:16.864 different environmental compartments, 40:16.860 --> 40:22.170 or chemicals that were used in food or environments that people 40:22.170 --> 40:25.150 frequent, foods that people eat a lot of 40:25.150 --> 40:28.140 or environments that were highly frequented, 40:28.139 --> 40:35.289 such as schools or such as occupational settings or homes. 40:35.289 --> 40:38.449 So that the idea of strategic attention on the most toxic 40:38.449 --> 40:40.479 chemicals is an important concept. 40:40.480 --> 40:46.270 So what's happened here as you think back across history? 40:46.268 --> 40:49.648 You've got kind of a sequence of changing regulatory 40:49.648 --> 40:50.508 priorities. 40:50.510 --> 40:52.750 And you might ask yourself, well, why is that? 40:52.750 --> 40:56.360 So that the first attempt back in 1906 was to protect the 40:56.364 --> 40:59.534 economy of farmers against fraudulent labeling. 40:59.530 --> 41:05.430 Then the obligation became to protect food and crop uses. 41:05.429 --> 41:10.009 So set limits for levels of residue in different kinds of 41:10.005 --> 41:10.655 foods. 41:10.659 --> 41:14.989 Then wildlife residues became extremely important as people 41:14.985 --> 41:19.675 worried about how chemicals were causing decline in species that 41:19.684 --> 41:23.344 were really much loved in the United States, 41:23.340 --> 41:26.290 particularly large raptors, bald eagles, 41:26.289 --> 41:29.219 the national symbol, or the gold eagle, 41:29.219 --> 41:32.909 the peregrine falcon, ospreys that now you can see 41:32.909 --> 41:37.049 coming back along the shoreline here in Connecticut, 41:37.050 --> 41:39.080 if you take the train from New Haven up to Boston, 41:39.079 --> 41:40.759 for example, and look out over the salt 41:40.755 --> 41:42.685 marshes, you'll see these poles sitting 41:42.690 --> 41:44.820 in the middle of salt marshes with ospreys. 41:44.820 --> 41:47.980 Ospreys came very close to extinction because of the 41:47.976 --> 41:51.686 chemical DDT that was building up in its body and causing its 41:51.688 --> 41:55.338 eggshells to thin so its reproductive success declined. 41:55.340 --> 41:59.010 Soil contamination became important as instances where a 41:59.012 --> 42:03.092 chemical had been used in the field one year and had persisted 42:03.086 --> 42:04.286 in that field. 42:04.289 --> 42:08.049 Another tenant farmer comes along the next year and plants a 42:08.054 --> 42:09.144 different crop. 42:09.139 --> 42:12.889 That crop is not permitted to have that chemical used on it, 42:12.885 --> 42:16.685 but it absorbed the chemical up through its roots and becomes 42:16.693 --> 42:17.713 adulterated. 42:17.710 --> 42:20.820 So that failure to think about soil contamination was causing 42:20.820 --> 42:23.570 some foods to become adulterated in ways that were not 42:23.570 --> 42:24.400 predictable. 42:24.400 --> 42:26.620 And drinking water contamination has come late to 42:26.617 --> 42:29.157 the attention of the Environmental Protection Agency. 42:29.159 --> 42:30.379 Why would that be? 42:30.380 --> 42:33.260 You know, if you think about water as one of the most 42:33.262 --> 42:35.262 consumed foods in the human diet, 42:35.260 --> 42:37.520 why wouldn't the government have paid more attention to 42:37.523 --> 42:37.863 water? 42:37.860 --> 42:40.390 Also think about indoor environments. 42:40.389 --> 42:44.279 I've come to believe that all of the attention given to food 42:44.277 --> 42:48.227 is really probably misplaced relative to exposures that occur 42:48.230 --> 42:50.010 in indoor environments. 42:50.010 --> 42:54.310 So that in many situations today, people can be in rooms 42:54.309 --> 42:58.139 when they are sprayed by a licensed applicator. 42:58.139 --> 43:01.489 So the exposures that occur after that often are far, 43:01.490 --> 43:04.970 far higher than the exposures that come from food-borne 43:04.972 --> 43:05.812 residues. 43:05.809 --> 43:09.109 The idea that the susceptible need attention, 43:09.105 --> 43:12.545 this is new in environmental law as of 1996. 43:12.550 --> 43:16.130 And new areas that deserve additional attention that I 43:16.130 --> 43:20.400 think are extremely important, is the use of these chemicals 43:20.402 --> 43:24.632 as they're impregnated into a variety of consumer products. 43:24.630 --> 43:29.050 So if you're hiking long distances, 43:29.050 --> 43:31.610 you may want a pesticide impregnated into the fabric that 43:31.614 --> 43:33.184 you buy, if you don't have an 43:33.181 --> 43:34.991 opportunity to wash your clothes. 43:34.989 --> 43:38.229 But what does that mean? 43:38.230 --> 43:41.550 There are a whole new array of products in the marketplace now 43:41.550 --> 43:44.760 that carry these residues, for obvious functions, 43:44.762 --> 43:49.482 such as durability, keeping them from degrading. 43:49.480 --> 43:52.140 Pesticides are added to paints, for example, 43:52.139 --> 43:55.799 to keep the bacteria in paint from breaking it down and 43:55.795 --> 44:00.055 chipping and causing you to have to repaint in a short period of 44:00.059 --> 44:00.669 time. 44:00.670 --> 44:03.680 So that the functional side of these chemicals used in consumer 44:03.682 --> 44:05.532 products is pretty well understood, 44:05.530 --> 44:09.030 but the long-term implications for environmental quality and 44:09.030 --> 44:10.810 human health really are not. 44:10.809 --> 44:15.539 So the underlying problems here include the human inability to 44:15.543 --> 44:17.253 sense chemical risk. 44:17.250 --> 44:20.070 You know, we basically don't know where these chemicals are 44:20.065 --> 44:22.195 in our environment because we can't see them, 44:22.202 --> 44:24.342 we can't taste them, we can't feel them. 44:24.340 --> 44:29.150 We have to imply where they are by proxy, thinking about 44:29.150 --> 44:34.660 "Gee, I'm living on a tract of land and I've got a well. 44:34.659 --> 44:36.429 And this used to be a farmland. 44:36.429 --> 44:37.789 Maybe I ought to test my drinking water." 44:37.789 --> 44:42.349 Or, "I'm living next to a field that is planted with a 44:42.349 --> 44:46.989 crop that's routinely sprayed by a plane that flies over. 44:46.989 --> 44:49.619 Maybe the drift is getting into my environment." 44:49.619 --> 44:53.369 So that thinking about where these things are in the 44:53.371 --> 44:57.421 environment really demands a certain level of background 44:57.420 --> 45:01.320 literacy and knowledge that often is not present. 45:01.320 --> 45:05.310 The underlying problem of lack of sensitivity to susceptibility 45:05.313 --> 45:06.733 is really important. 45:06.730 --> 45:08.120 Who's susceptible? 45:08.119 --> 45:09.689 Well, the very youngest are. 45:09.690 --> 45:13.620 And remember that all these concentrations are measured how? 45:13.619 --> 45:15.799 They're expressed per unit of your body weight. 45:15.800 --> 45:20.970 So when in life does a human have the lowest body weight? 45:20.969 --> 45:24.699 In utero, first trimester. 45:24.699 --> 45:30.499 So if the concentration in the mom is the same moving across 45:30.496 --> 45:35.406 the placenta as the concentration in the fetus, 45:35.409 --> 45:38.929 and you get to an exposure estimate by taking that 45:38.925 --> 45:42.365 concentration and dividing it by body weight, 45:42.369 --> 45:46.099 and the mom's body weight might be 160 pounds and the fetus' 45:46.099 --> 45:48.879 body weight might be a quarter of a pound. 45:48.880 --> 45:50.960 I'm sorry Laura, about this. 45:50.960 --> 45:54.700 You get the idea. 45:54.699 --> 45:58.239 The same concentration in the environment affects the fetus 45:58.242 --> 46:00.932 much more than it would the average adult. 46:00.929 --> 46:03.459 So this has really transformed the way that government 46:03.456 --> 46:06.266 regulators have begun to think about chemical management. 46:06.268 --> 46:08.688 We've had poor monitoring of chemical release. 46:08.690 --> 46:11.990 We have thought much more about chemical persistence and 46:11.985 --> 46:15.215 environmental fate having learned from strontium-90 and 46:15.221 --> 46:16.301 the DDT story. 46:16.300 --> 46:20.400 And we've misunderstood variability in human exposure. 46:20.400 --> 46:24.240 Still we're not putting monitors on individual people. 46:24.239 --> 46:28.259 Although increasingly, the government is monitoring 46:28.262 --> 46:31.712 human tissue, taking blood and urine and hair 46:31.710 --> 46:35.610 samples to try to figure out what the matrix of chemicals 46:35.612 --> 46:38.752 might be that an individual is exposed to. 46:38.750 --> 46:42.650 So looking not just by sampling in the marketplace, 46:42.650 --> 46:48.220 but looking at this pattern by taking human tissue samples, 46:48.219 --> 46:51.699 this is a whole new wave that's giving people the opportunity 46:51.704 --> 46:53.974 literally to go to a doctor and say, 46:53.969 --> 46:56.889 "I want to be measured for this entire array of 46:56.889 --> 46:57.919 chemicals." 46:57.920 --> 47:00.430 So it may cost you a couple thousand dollars to go through 47:00.425 --> 47:02.385 that process, but increasingly people are 47:02.385 --> 47:05.065 doing this, trying to make some sense out 47:05.065 --> 47:08.805 of the way that they feel, their medical condition, 47:08.806 --> 47:10.756 and environmental quality. 47:10.760 --> 47:13.880 Single chemical exposure is still the focus of government. 47:13.880 --> 47:17.340 No company wants its chemical to be compared to another 47:17.342 --> 47:20.552 company when they're making a regulatory choice. 47:20.550 --> 47:24.910 Toxicity testing is incomplete in a variety of areas, 47:24.907 --> 47:28.507 especially relative to the immune system. 47:28.510 --> 47:31.170 And you know the rise in allergies that we're 47:31.172 --> 47:33.172 experiencing, severe allergies. 47:33.170 --> 47:37.350 More people are walking around with Epi-Pens today because of 47:37.347 --> 47:40.477 worries about anaphylaxis than ever before. 47:40.480 --> 47:42.500 Something is happening to the human immune system. 47:42.500 --> 47:45.470 It's not clear why, but many of the chemicals that 47:45.474 --> 47:47.724 are released, such as some pesticides, 47:47.719 --> 47:50.209 do influence the human immune system. 47:50.210 --> 47:53.460 That's one example of an area of human health that has been 47:53.458 --> 47:55.138 neglected by the government. 47:55.139 --> 48:00.769 Also, the endocrine effects are quite misunderstood. 48:00.768 --> 48:05.538 The behavior of these chemicals as human hormones--that we'll 48:05.543 --> 48:07.933 speak about a bit next week. 48:07.929 --> 48:10.849 Also, failure of labeling as a management strategy. 48:10.849 --> 48:13.809 Labeling is still the dominant approach that EPA takes to try 48:13.813 --> 48:16.793 to inform the public, to educate the public how they 48:16.793 --> 48:20.383 might be able to use these economic poisons in as safe way. 48:20.380 --> 48:22.750 But you need to think about whether or not that's really a 48:22.748 --> 48:24.988 potentially effective way of controlling these kinds of 48:24.994 --> 48:25.414 risks. 48:25.409 --> 48:29.479 And we're also misunderstanding trends in human illness. 48:29.480 --> 48:33.360 For example, we had no asthma registry in 48:33.356 --> 48:35.776 Connecticut until 2003. 48:35.780 --> 48:39.660 So we couldn't figure out whether or not people that lived 48:39.655 --> 48:43.525 in areas that have had higher levels of air pollution were 48:43.532 --> 48:45.642 more likely to have asthma. 48:45.639 --> 48:49.839 So the absence of surveillance of health conditions makes it 48:49.842 --> 48:54.192 impossible to correlate these exposures to health outcomes. 48:54.190 --> 48:56.950 And finally, a variance in human capacity to 48:56.951 --> 48:57.851 manage risk. 48:57.849 --> 49:00.929 There's a real environmental justice issue here that needs to 49:00.934 --> 49:04.114 be paid attention to, that there are many members of 49:04.112 --> 49:07.802 society that do not have the capacity to get the education 49:07.802 --> 49:09.942 necessary to self-manage risk. 49:09.940 --> 49:14.390 So that some people simply are more reliant on government 49:14.385 --> 49:17.635 standard setting than other people are. 49:17.639 --> 49:20.979 So these are all underlying problems of law, 49:20.980 --> 49:25.720 and all of them are pretty well exemplified by this history of 49:25.717 --> 49:27.577 pesticide management. 49:30.090 --> 49:32.810 And we'll come back on Tuesday. 49:32.809 --> 49:34.069 Have a great weekend. 49:34.070 --> 49:39.000