Natural Resources Defense Council has fought for 50 years to make EPA enforce chemical safety standards
WASHINGTON D.C.––How has the Natural Resources Defense Council, whose emblem is a polar bear, become the front line of public defense of the animal testing industry?
Why is Environmental Protection Agency administrator Andrew Wheeler leading the most aggressive effort yet by any branch of the U.S. government to phase out animal testing entirely?
Wheeler, described by Washington Post staff writer Karin Brulliard as “a former coal lobbyist who has championed the Donald Trump administration’s rollback of environmental regulations,” on September 10, 2019 released to media a June 2019 memo to EPA staff which, in Wheeler’s own words, “directs the agency to aggressively reduce animal testing, including reducing mammal study requests and funding 30% by 2025, and completely eliminating them by 2035.”
“Commitment to move away from animal testing”
Confirmed as EPA administrator in February 2019, Wheeler in a March 2019 “all hands” staff meeting “reiterated the U.S. Environmental Protection Agency’s commitment to move away from animal testing,” he recalled in the written memo.
“We are already making significant efforts to reduce, replace and refine our animal testing requirements under both statutory and strategic directives,” Wheeler said.
In the memo, Wheeler also announced that the EPA is “awarding $4.25 million to advance the research and development of alternative test methods for evaluating the safety of chemicals that will minimize, and hopefully eliminate, the need for animal testing.”
The funding was allocated among Johns Hopkins University, whose Center for Alternatives to Animal Testing, founded in 1981, is the oldest in the U.S.; Vanderbilt University and the Vanderbilt University Medical Center; Oregon State University at Corvallis; and the University of California, Riverside.
“Yet another Trump administration attack on scientific information”
Furiously responded Natural Resources Defense Council senior scientist Jennifer Sass, “This is yet another Trump administration attack on scientific information, this time targeting the laboratory animal tests that show whether and how chemicals may harm people, wildlife, and ecosystems.”
Charged Sass, “The Trump EPA is pushing the use of non-animal alternative methods that are mostly still in development, and cannot capture the complexity of many chemical exposure risks like infertility and cancer.”
But the Wheeler memo was welcomed by the Humane Society of the U.S., People for the Ethical Treatment of Animals, and the Physicians Committee for Responsible Medicine, all of whom have conflicted with both the Natural Resources Defense Council and the Trump administration on multiple fronts over the years. All sent representatives to the release of the memo to media.
White Coat Waste Project
Also appearing with Wheeler at the memo announcement were representatives of the six-year-old White Coat Waste Project, an antivivisection society founded by former Republican campaign strategist Anthony Bellotti, focusing on the premise that funding animal-based biomedical research amounts to wasting tax money.
Bellotti previously directed campaigns to defund Planned Parenthood and kill Obamacare, thereby developing contacts and influence within the Trump administration that few other animal advocates can claim.
Beginning years before that, however, Bellotti was from 2006 to 2013 associated with the Seattle-based Humane Research Council, founded by Che Green, prominent in Seattle animal advocacy on multiple fronts for more than 25 years.
Bellotti and the White Coat Waste Project were in January 2016 among the first––perhaps the very first––to clash with the then newly inaugurated Trump administration over the deletion of Animal Welfare Act enforcement data from the USDA Animal & Plant Health Inspection Service web site.
Wheeler on record against animal testing since 1987
Wheeler “described the subject [of reducing animal testing] as one of personal importance to him,” wrote Brulliard. “Wheeler’s staff gave reporters copies of a 1987 column he had written for [the Case Western Reserve University] newspaper that called for decreasing animal testing.”
Said Wheeler, “When I wrote this article back in 1987, I didn’t think we were that far away from banning animal testing. Part of why I’m doing this today is it’s been 30 years, and we haven’t made enough progress.”
Continued Brulliard, “Wheeler said that he had ‘not been lobbied by a single chemical company’ on the topic, which he said was ‘of long-standing interest to me personally.’ When he was young, he said, his mother told him about ‘the ethical problems’ of animal testing, and he added that one of his sisters is a zoologist and another a veterinarian.”
“Several decades needed,” as of more than a decade ago
NRDC scientist Sass conceded that, “While the EPA is warranted in taking steps to develop non-animal methods that provide information of equal or better quality—including funding additional research—it should not be setting artificial deadlines or prematurely eliminating funding or preventing the use of animal tests needed to inform and protect the public.
“In 2007,” Sass recalled, “the National Academies of Sciences suggested in their groundbreaking report Toxicity Testing in the 21st Century that several decades would be needed for scientists to develop the necessary biological understanding to completely replace animal tests in our chemical evaluations paradigm. Though scientists have made great strides in advancing our understanding of chemical behavior,” Sass said, “there is still some distance left to travel.”
“Animal testing has perhaps misled us”
But as Wheeler pointed out, “Oftentimes we find that animal testing has perhaps misled us on the science, and there are better alternatives for testing the impacts of chemicals on people.”
Summarized Broulliard, “Wheeler described the directive as a continuation of efforts that accelerated in 2016, under the Obama administration, when the Toxic Substances Control Act was amended to require the EPA to reduce its reliance on animal testing.”
Unfortunately, the Toxic Substances Control Act was not effectively implemented during the first two years of the Trump administration.
Instead, explained Science writer Vanessa Zainzinger in May 2018, “The number of animal tests requested or required by the Environmental Protection Agency jumped dramatically, from just a few dozen tests involving fewer than 7,000 animals in 2016, to more than 300 tests involving some 75,000 rats, rabbits, and other vertebrates” in 2017.
More animal tests under 2016 law meant to reduce them
“The cause of the increase isn’t clear,” Zainzinger said. “But the new law imposes stricter requirements on a broader array of chemicals than its predecessor, including both new products and ones already on the market, and experts say EPA staff may be trying to comply by gathering more test data from companies. Both industry and animal welfare groups,” specifically PETA and PCRM, “are alarmed by the trend, and are asking agency officials to clarify why they are requesting the tests—and how they plan to reduce the number in the future,” Zainzinger wrote.
According to a joint statement submitted by PETA and PCRM to the EPA, the EPA in 2015 required 21 tests using 8,881 animals; in 2016, it required 37 tests using 6,539 animals; and in 2017, the first full year that the Toxic Substances Control Act was in effect, it required 331 tests using 76,523 animals.
The current conflict between Wheeler and the Natural Resources Defense Council over the value and efficacy of animal testing amounts to re-ignition of a multi-generational running battle that long predates the existence of the NRDC and the EPA, both formed in 1970.
Clash began with the 1952 Delaney clause
The fight began with a 1952 amendment to the then existing federal food and drug safety testing requirements, called the Delaney clause, named for then-House of Representatives Select Committee on Food Chemicals chair James J. Delaney, of New York.
The amendment stated, in full, “No additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal.”
The latter two words became the mandate for most consumer product animal testing done over the next 38 years.
Incorporated into the Food Additives Amendment to the Food, Drug, & Cosmetic Act of 1958, and the Color Additives Amendment of 1960, the Delaney Clause became the first line of regulatory defense of the American public against chemical carcinogens.
“800 soft drinks a day”
The Delaney clause, for example, was why the FDA banned root beer flavored with safrole from natural sassafras leaves in 1960; banned soft drinks using cyclamate sweeteners in 1966; and banned all use of saccharin sweeteners in 1977.
Each time much of the public, and even some of the officials who enforced the Delaney clause, were incredulous about the application to human health of rodent testing data showing that the animals might develop tumors from ingesting the equivalent of “800 soft drinks a day,” as acting Food & Drug Administration commissioner Sherwin Gardner put it in 1977.
Yet the Delaney clause withstood all criticism, even though it was never demonstrably effective, because no one in politics wanted to take the risk of being labeled “pro-cancer.”
When the Delaney clause was adopted, only 424 chemicals of about 700 commonly used in food production had ever been safety tested. By 1993, Physicians Committee for Responsible Medicine researcher Alix Fano wrote to The New York Times, “of some 70,000 chemicals on the market, almost half in common use, only 800 had undergone standard rodent tests used to try to predict human cancer risk.”
The chemical industry had outgrown the testing methods.
“The cost of running a typical pre-chronic and long-term rodent carcinogenicity bioassay is $1.6 million to $2.5 million per chemical,” Fano continued. “With more than 25,000 commonly used chemicals awaiting evaluation, to test them all would cost $50 billion to $75 billion,” at that just a fraction of what similar testing would cost today.
Pressured by both consumers and industry, the Food & Drug Administration and other regulatory bodies circumvented the Delaney clause, when they could, to keep essential and/or simply popular chemicals on the market.
One example was saccharin, which would have been banned in 1972 had the Delaney clause been rigidly enforced. Saccharin was instead kept in a special “interim regulation” category during five years of retesting.
1992 NRDC court victory killed Delaney
After a dozen years of battling Ronald Reagan administration efforts to roll back environmental and public health regulations on multiple fronts, which continued under Reagan’s successor, George H. Bush, the Natural Resources Defense Council in July 1992 won a Federal Appellate Court verdict that obliged the EPA to enforce the Delaney clause to the letter.
This meant suspending the registration of the pesticides most commonly used on 33 food crops.
Taking office six months later with strong support from agribusiness, the Bill Clinton administration quietly made dismantling the Delaney clause a priority.
The effort gained momentum from a June 1996 report by the Commission on Risk Assessment & Risk Management, established by Congress under the Clean Air Act Amendments of 1990. The commission report argued that finding a chemical causes cancer in rodents is irrelevant when the mechanism enabling the cancer to develop is not found in humans.
The repeal bill, the Food Quality Protection Act of 1996, was the only environmental bill to win unanimous support from the 104th Congress.
High Production Volume Challenge
No animal protection group claimed victory. No environmental or consumer protection group, not even the Natural Resources Defense Council, bewailed defeat.
Yet repeal of the Delaney clause meant that animal test results were no longer the official regulatory standard for assessing cancer risk to human beings. The U.S. chemical safety standard became just the probability of carcinogenic effect on human beings, as indicated by data pertaining directly to human tissues.
Two years later, in 1998, the EPA and then-U.S. vice president Al Gore announced a six-year program to test 2,800 major industrial chemicals to measure their toxicity and analyze possible health risks to humans going far beyond just the risk of causing cancer.
The EPA High Production Volume Challenge, as it was called, was introduced along with the Voluntary Children’s Chemical Evaluation Program and the Endocrine Disrupter Screening Program, both of which also represented significant expansions of animal testing to look at aspects of chemical safety which had not even been recognized when the Delaney clause was enacted.
PETA vs. Environmental Defense Fund
The Environmental Defense Fund, pursuing testing of all chemicals in common use since 1967, often in alliance with the Natural Resources Defense Council, in January 1999 reached agreement with the Chemical Manufacturers Association on a High Production Volume Challenge research protocol which emphasized finding ways to meet the expanded testing requirements by extracting more information from the results of animal tests already conducted.
Despite that, PETA ripped the protocol in a mass mailing for allegedly proposing to kill “millions of animals” in redundant tests using obsolete methods.
Then the issue heated up further.
American Petroleum Institute vs. American Anti-Vivisection Society
The American Petroleum Institute agreed to administrate the Petroleum High Production Volume Testing Group, a consortium of 70 companies belonging either to the American Petroleum Institute itself, the National Petrochemical & Refiners Association, the Gas Producers Association, and/or the Asphalt Institute.
Together these companies represented 92% of U.S. refinery capacity.
Under then-American Petroleum Institute chief toxicologist Lorraine Twerdok, who retired in 2005, the consortium submitted to the EPA a proposed High Production Volume Challenge response which reduced the number of fossil-derived substances requiring new risk evaluations from the original 425 to 167, and cut the anticipated volume of animal testing needed to do those risk evaluations by 90% from the 1998 EPA estimate.
The American Anti-Vivisection Society, in particular, tore into that as “a plan to kill thousands of animals in a series of unnecessary toxicity tests of butane, propane, and coal dust. Needless animal suffering will take place,” AAVS charged, “because the American Petroleum Institute insists on reproducing data that is already available.”
NRDC remains skeptical
The chemical industry protocols for meeting the EPA High Production Volume Challenge were eventually accepted. The High Production Volume Challenge program is now completed, at an unknown cost in animal lives, since the federal Animal Welfare Act does not require tracking or publication of statistics on the use of mice, rats, fish, birds, reptiles, and amphibians.
The Natural Resources Defense Council, however, has never been happy with the outcome, arguing that the chemical industry has managed to evade regulation by, as NRDC scientists Jennifer Sass and Daniel Rosenberg argued in an October 2011 report called The Delay Game, “manipulating the regulatory process to prevent science-based assessments of toxicity and human health risks from becoming policy.”
Rosenberg in January 2018 charged that under the Trump administration, “The EPA’s toxics office became a wholly-owned subsidiary of Dow-Dupont, Exxon, “Chemours” and other chemical manufacturers, and in that time has been transformed into the Make a Wish Foundation for the chemical industry,” including by “Weakening new rules for evaluating the risks of toxic chemicals under the Toxic Substances Control Act, challenged in court by numerous groups including NRDC.”
“Better alternatives for testing impacts of chemicals on people”
In light of 50 years of litigation waged to oblige the chemical industry to comply with even the relatively weak safety testing requirements in effect as of 1970, while millions of Americans died preventable deaths, the Natural Resources Defense Council is understandably wary of anything that looks like giving up hard-won gains.
But in light of the many failures of animal testing to protect the public, including in the cases of asbestos, tobacco, and some pesticides, in which animal testing results were manipulated to “disprove” hazards that also killed millions, it is difficult to argue that Wheeler was wrong in stating that “Oftentimes we find that animal testing has perhaps misled us on the science,” and in asserting that “There are better alternatives for testing the impacts of chemicals on people.”