{"id":137225,"date":"2019-07-08T12:00:00","date_gmt":"2019-07-08T11:00:00","guid":{"rendered":"https:\/\/www.transcend.org\/tms\/?p=137225"},"modified":"2021-02-19T09:57:56","modified_gmt":"2021-02-19T09:57:56","slug":"the-us-environmental-protection-agency-move-to-phase-out-animal-experiments-could-mean-the-end-of-toxics-regulations","status":"publish","type":"post","link":"https:\/\/www.transcend.org\/tms\/2019\/07\/the-us-environmental-protection-agency-move-to-phase-out-animal-experiments-could-mean-the-end-of-toxics-regulations\/","title":{"rendered":"The US Environmental Protection Agency Move to Phase Out Animal Experiments Could Mean the End of Toxics Regulations"},"content":{"rendered":"
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Illustration: Soohee Cho\/The Intercept<\/p><\/div>\n

3 Jul 2019 – <\/em>The Environmental Protection Agency is moving forward with a plan to sharply reduce and ultimately phase out experimental testing on lab animals. In an undated internal memo\u00a0sent in late June to assistant administrators, EPA chief Andrew Wheeler explained that the agency will cut its funding for experiments on mammals in half by 2025. The memo, which was reviewed by The Intercept, also said that the EPA plans to stop using mammal studies for the approval of new chemicals by 2035 and that it will\u00a0aim to eliminate all mammal studies. Under the new plan, any animal study done after that point will require approval by the EPA administrator.<\/p>\n

The EPA is promoting alternative methods to gauge the threats posed by chemicals, such as computer modeling and tests on cells, which have been increasingly used in recent years. Yet no legal limits have ever been set using these alternative methods alone. Without the tests on rats, mice, and rabbits currently used to gauge the toxicity of chemicals and set safe levels, public health and environmental advocates worry that the policy shift will leave EPA unable to limit chemicals at all. \u201cIt effectively will mean you can\u2019t regulate,\u201d said Jennifer Sass, a senior scientist at the Natural Resources Defense Council.<\/p>\n

The internal announcement that EPA would speed the move away from animal testing coincided with the creation of a new section<\/a> on the agency\u2019s website that was published last week. Titled \u201cAlternative Test Methods and Strategies to Reduce Vertebrate Animal Testing,\u201d the newly\u00a0released material details the EPA\u2019s efforts to \u201creduce and replace testing on vertebrates.\u201d On March 14, Wheeler signaled that he would be making the shift in a speech<\/a>, broadcast internally to EPA staff, in which he described the animal testing issue as \u201cimportant to me personally.\u201d<\/p>\n

The chemical industry also appears to care deeply about the reduction of animal research, according to emails of EPA staff released in June in response to a Freedom of Information Act request. The American Chemistry Council, the largest American trade group representing chemical manufacturers, has long supported reducing regulators\u2019 reliance on animal research, which\u00a0is time-consuming and expensive \u2014 in addition to being key to understanding the harms chemicals pose to people.<\/p>\n

The End of Chemical Regulation<\/strong><\/p>\n

A new generation of tests using cultured cells and\u00a0computer simulation has expanded the ability to understand the risk compounds pose without using animals. Because\u00a0it is not possible to perform animal tests for\u00a0every one of the huge and growing number of man-made chemicals, these techniques, which can be done more quickly and cheaply, have become increasingly important.<\/p>\n

But many scientists who study chemicals caution that research on cells or tiny invertebrate creatures, known as \u201cin vitro toxicology,\u201d cannot completely replace mammal experiments yet. \u201cIf you take the engine out of a car and study one piston at a time, it may not tell you what the car is going to do when you assemble it,\u201d said Thomas Zoeller, a biologist at the University of Massachusetts Amherst who studies the health effects of man-made chemicals like polychlorinated biphenyls.<\/p>\n

Zoeller\u2019s own research revealed that, within mice, it\u2019s not the actual PCB that causes harm but another chemical that the body creates by processing the original compound \u2014 a discovery that wouldn\u2019t have been possible without exposing live mice to the chemical. \u201cThe parent compound gets into the animal and is metabolized in some tissues, including the brain. The body essentially bioactivates the parent compound,\u201d Zoeller explained.<\/p>\n

\u201cIf you exclusively depend on in vitro toxicology or mathematical modeling, you\u2019re going to miss all the different interactions that happen in a physiological system \u2014 whether in rat, mouse, human, or a fetus. You simply cannot replicate that,\u201d said Zoeller. \u201cEPA is well aware that these cells don\u2019t replicate human metabolism. So when it comes to bioactivation, they\u2019re going to miss all that \u2014 and they know that.\u201d<\/p>\n

And that, some scientists fear, is exactly the reason the EPA is moving toward eliminating tests on animals. \u201cIf you require that, to regulate, you need to show an adverse affect for a chemical, and you can\u2019t see an adverse affect in cells, then it\u2019s to your benefit to only do testing in cells,\u201d said Laura Vandenberg, a professor at UMass Amherst\u2019s School of Public Health, who studies how exposures to chemicals during the development affects health later in life. \u201cLaws, policy, and regulations require animal evidence.\u201d<\/p>\n

While regulatory rules can be updated to reflect new methods, it\u2019s not clear how non-animal experiments would ever lead to restrictions. With animal tests, the presence of a clear endpoint such as cancer or birth defects helps regulators calculate safe levels for humans. But a positive finding in a non-animal test will likely only lead to more research, according to NRDC\u2019s Sass.<\/p>\n

\u201cLet\u2019s say they do find a hazard in a chemical. Let\u2019s say it triggers changes associated with cancer. They don\u2019t then call it a carcinogen. They just prioritize it for further testing,\u201d said Sass, who has a PhD in anatomy and cell biology. \u201cThen they test it on higher level tests, then on higher level tests. So if it is something that\u2019s toxic, we\u2019ll still go through years and years of testing and arguing and fighting.\u201d<\/p>\n

Now People Are the Guinea Pigs<\/strong><\/p>\n

In 2006, the EPA\u2019s National Health and Environmental Effects Research Laboratory published a study<\/a>\u00a0showing that pregnant mice given the industrial chemical PFOA\u00a0developed enlarged livers and had a greater chance of losing their pregnancies. The pups of the exposed mice weighed less and were developmentally delayed compared to the non-exposed pups, and the male\u00a0pups had abnormal sexual development. While the EPA has yet to set a legal limit<\/a> for PFOA, the agency used the mouse study to set a health advisory level for the chemical in 2009. And some states have used it to calculate their own regulations.<\/p>\n

But since NHEERL did that groundbreaking work, the number of scientists leading animal research there has shrunken by more than half. The lab employed 56 principal investigators who conducted 139 active protocols involving animals in 2008, according to the EPA press office. This year, only 24 principal investigators were left, conducting 52 experiments involving lab animals. At another EPA lab focused on animal toxicology, the National Exposure Research Laboratory, the number of active protocols involving animals has dropped from 20 in 2008 to 13 in 2019. And neither lab will continue to exist after a planned reorganization<\/a> of the Office of Research and Development is complete. Indeed, under the new structure, no labs that focus exclusively on animal research will remain.\u00a0In his memo, Wheeler noted that 200,000 lab animals have already been spared from testing in recent years.<\/p>\n

As Wheeler has embraced the adoption of new testing methods, the EPA has teamed up with animal rights groups such as PETA<\/a> that oppose animal research because they see it as cruel. In April, the EPA co-sponsored a webinar<\/a> on alternate methods of chemical assessment with PETA International Science Consortium and Physicians Committee for Responsible Medicine; the latter group is\u00a0closely affiliated with the animal rights organization.<\/p>\n

But it seems unlikely that the real issue for Wheeler, a former coal lobbyist reported to have invested in a burger restaurant<\/a>, is animal welfare. Internal EPA communications point to the chemical industry\u2019s interest in the alliance with animal rights groups. In a July 2017 email<\/a> to representatives of Dow Chemical, Exxon Mobil, Syngenta AG, the American Chemistry Council, PETA International, and the EPA, Michael Dourson<\/a>\u00a0\u2014 Trump\u2019s failed nominee to lead the EPA\u2019s chemical safety division \u00a0\u2014\u00a0proposed an Institute of Predictive Safety Assessment that would bring PETA together with the industry to help shift the thinking on testing, as E&E News reported<\/a> that year.<\/p>\n

The recently released batch of emails included one sent three months later to Nancy Beck, who then ran the EPA\u2019s toxics office, and Dourson from Daland Juberg, who identified himself as heading human health science for DowDuPont. In it, Juberg inquired about the institute\u2019s progress. \u201cLet\u2019s talk down the road on areas where EPA might have interest in moving the needle,\u201d Juberg wrote.<\/p>\n

While animal rights activists have focused on the ethics of exposing innocent creatures to toxic substances, by allowing chemicals onto the market without first testing their safety, people have essentially become the guinea pigs. Residents of Wilmington, North Carolina, may feel that particularly acutely. After the chemical GenX<\/a> was discovered<\/a> in the Cape Fear River downstream from a factory owned first by DuPont and now its spinoff, Chemours, researchers tested the blood of people who have been drinking the water and found four<\/a> PFAS chemicals that had never been\u00a0publicly identified, let alone studied.<\/p>\n

\u201cDo they have health effects? Which of the chemicals we found in their blood are related to high cholesterol? Which cause elevated liver enzymes?\u201d asked Jane Hoppin, deputy director of the Center for Human Health and the Environment at North Carolina State University, which is conducting the blood study<\/a>. \u201cThese poor people have been drinking these chemicals for 40 years, and we have nothing to offer them.\u201d<\/p>\n

With mysterious chemicals posing unknown harms within their own bodies, the people of Wilmington deserve more than cursory research, said Hoppin. \u201cYou can do a lot of quick testing in a petri dish,\u201d she said. \u201cBut to see what really happens, you need a mammal.\u201d<\/p>\n

\u201cLooking Forward to Collaborations!\u201d<\/strong><\/p>\n

Beck<\/a>, who directed regulatory science policy for the American Chemistry Council before Trump appointed her to run EPA\u2019s toxics office in 2017, exchanged emails about the use of alternative techniques to replace animal testing with several chemical company representatives, including Dennis Deziel, director of federal government affairs for Dow Chemical.<\/p>\n

\u201cDow is a leader in non-animal testing methods,\u201d Deziel wrote to Beck in July 2017. \u201cWe want to engage on this issue in as helpful way as possible.\u201d Beck met with Deziel and other Dow staff a few weeks later, according to the emails. \u201cExtremely helpful for us,\u201d Deziel wrote to Beck afterward.<\/p>\n

Also at the meeting was Louis Scarano, an EPA toxicologist, who held at least one other meeting at which the issue was discussed with Deziel\u2019s colleague, Sue Marty, Dow Chemical\u2019s toxicology science director.<\/p>\n

\u201cI really appreciate your time and I enjoyed our conversation,\u201d Marty wrote in an email to Scarano after that meeting, which was in mid-August 2017. \u201cI think we share similar views on how alternate approaches could be used in the TSCA program,\u201d she wrote, in a reference to the Toxic Substances Control Act, the primary federal law governing chemical regulation.<\/p>\n

\u201cLooking forward to collaborations!\u201d the EPA\u2019s Scarano responded. Scarano is now listed as the contact person for people seeking information on how the agency plans to reduce animal testing in TSCA as well as under other laws that involve chemical regulation.<\/p>\n

Dow, it should be noted, is the maker of many chemicals that fall under the EPA\u2019s purview and have been subject to animal testing, including chlorpyrifos<\/a>, a pesticide linked to neurodevelopmental problems that the EPA found dangerous enough to ban in 2016; 1,3-butadiene<\/a>, a chemical that a division of the EPA recently found \u2014 using animal testing \u2014 to cause cancer as well as reproductive and developmental problems; and ethylene oxide<\/a>, another compound the EPA recently assessed<\/a>. The EPA set the safety threshold for that chemical, which has caused elevated cancer risks in more than 50 places<\/a> around the U.S., using studies showing ethylene oxide caused tumors of the brain, lung, connective tissue, uterus, and mammary glands of mice and rats.<\/p>\n

Even before the recent industry push and policy shift at EPA, the federal regulation of chemicals had slowed to a near standstill. Only a small handful of the more than 40,000 chemicals now in use have been regulated. An overhaul of the 40-year-old Toxic Substances Control Act law in 2016 was supposed to finally fix that. The updated law<\/a> gave the agency new authority to require testing. Since the Trump administration took office, however, the agency appears not to have taken advantage of its new powers.<\/p>\n

\u201cIn the nearly 3 years since passage of TSCA reform, EPA has not once used these new authorities and seems to be avoiding them at all costs,\u201d Democratic Senators Cory Booker, Tom Udall, Ed Markey, Jeff Merkley, and Sheldon Whitehouse wrote<\/a> to EPA administrator Wheeler on June 20.<\/p>\n

Meanwhile, the Trump administration has advanced another provision of the updated law: language that requires the EPA to rely on non-animal tests when they\u2019re as good as or better than the animal research. The EPA\u2019s materials detailing its shift away from animal testing repeatedly cite the directive. But as the senators pointed out in their letter, \u201cThe law\u2019s vertebrate animal testing provisions in no way limit EPA\u2019s testing authorities; they simply call for EPA to rely on methods not involving vertebrate animals where such methods can provide equivalent or better scientific quality and relevance than vertebrate tests.\u201d<\/p>\n

Nor does TSCA, only one of the laws under which EPA\u00a0is authorized to conduct animal tests, explain why the new directive will affect research throughout the agency, including in its water and pesticide divisions. Nevertheless, according to\u00a0Wheeler\u2019s memo, work to finalize the shift away from animal testing will begin immediately.<\/p>\n

____________________________________________<\/p>\n

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 <\/p>\n

Sharon Lerner<\/a> – sharon.lerner@\u200btheintercept.com<\/a> <\/em><\/p>\n

 <\/p>\n

 <\/p>\n

Go to Original \u2013 theintercept.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

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