AV Magazine Issue 1, 2019

A PUBLICATION OF THE AMERICAN ANTI-VIVISECTION SOCIETY 2019 | Number 1

magazine

CHEMICAL TESTING ON ANIMALS: DRIVING CHANGE

WHERE CAN WE EXPECT TO GO FROM HERE? pg 12

AN INTERVIEW WITH SENATOR CORY BOOKER pg 14

2019 Issue 1

Chemical Testing on Animals: Driving Change

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FEATURES

4 CHEMICAL TESTING REFORM THE GAME PLAN FOR

Playing offense and defense to reach the goal of reducing animal-based tests.

By Martin Stephens

8 DEPARTMENTS 1 First Word A new law sets the stage.

2 Briefly Speaking Challenges to Chimp Retirement; ARDF Funds Models to Replace Animals; China Slow to Go Cruelty-Free; Japan, South Korea Stop Testing Pesticides on Dogs; USDA Needs to Do Better, Says Accountability Office.

16 Giving Developing and promoting alternatives advances science.

6 How We Got There: Reauthorizing the Toxic Substances Control Act A variety of problems and issues led to the 2016 legislation to revamp government-sponsored testing.

By William Bellamy and Paul Locke

8 Moving Chemical Testing Away from Animals Years of lobbying and collaboration among various interests got greater animal protection measures put into law.

By Kristie Sullivan, Sara Amundson, and Catherine Willett

10 The Impact of the LCSA on Animal Use It will take continued vigilance to move the Environmental Protection Agency toward more humane practices.

By Joseph Manuppello and Jessica Sandler

12 Where Can We Expect to Go from Here?

New methodologies are key to implementing a strategic plan for the future.

By Catherine Willett 14 Interview: Cory Booker The U.S. Senator from New Jersey helped lead a bipartisan effort to prioritize non-animal alternatives.

20 Members’ Corner Rabbits as symbols and survivors of animal testing.

Founded in 1883, the American Anti-Vivisection Society’s (AAVS) mission is to unequivocally oppose and work to end experimentation on animals and to oppose all other forms of cruelty to animals. AAVS is a nonprofit education organization using legal, effective advocacy to achieve meaningful, lasting change.

PHOTOS ON FRONT AND BACK COVERS BY ISTOCK

16 Tributes Special friends honored and remembered.

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magazine

VOLUME CXXVII Number 1 ISSN 0274-7774

Executive Editor Sue A. Leary Managing Editor and Copy Editor Jill Howard Church Staff Contributors Jill Howard Church Chris Derer Crystal Schaeffer Art Direction Brubaker Design

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articles that appear in AV Magazine. In all cases, we will require that credit be given to the author and to AAVS. The individual views and claims expressed in AV Magazine are not necessarily those of the organization.

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First Word IN 1999, I MET SCIENTISTS and government regulators in Europe at my first conference on alternative testing and was (pleasantly!) surprised at their determination to develop non-animal methods. I learned that part of what drove them was the United Kingdom’s ban of cosmetics testing on animals in 1998, which the European Union later followed with its own ban in 2003.

There and here, laws set boundaries, define issues, and set in motion a cascade of actions. Europe’s ban on animal testing ushered in a new era for development of alternative methods so responsible companies could continue creating new products, with new ingredients, and remain in compliance. Governments invested in studies of alternative methods to determine which ones worked best for verifying safe products.

Years later in the U.S., regulatory attention turned to toxic chemicals, the testing of which involves tremendous pain and suffering for millions of animals. Thanks to a convergence of great science, cooperative companies, persevering and united animal advocates, legislators who wanted to do the right thing, and other factors, a compromise was reached and sweeping changes to the Toxic Substances Control Act (TSCA) were passed in 2016.

This issue of AV Magazine examines what led to that moment, and the changes that have resulted. One important lesson is that the passage of a law is far from the end of the story. Federal agencies enforce laws, and to do so, they mull every provision in order to issue plans and regulations. Each decision is molded by pressure from internal and external forces. I’ve reviewed many documents and attended many meetings where these decisions are hashed out, and added AAVS’s voice, trying to advance alternative methods that spare animals.

We hope that you find this issue to be a good case study for gaining insight on how change is made—and come away with a better understanding that, if we want to help the world become a better place for animals, we need to pay attention and participate in policymaking.

As I write this, I am on a train on my way home from meetings in Washington, D.C. with scientists and lawmakers. AAVS’s message is particularly well-received when I talk about the great work being done by recipients of grants made by our Alternatives Research & Development Foundation, illustrating new non-animal research and testing methods that are pointing the way to progress. And now, with this revised TSCA law coming into effect, there are strong incentives to make use of that new technology. Thank you for making it possible!

Sue A. Leary, President, American Anti-Vivisection Society

Briefly Speaking NEWS YOU NEED TO KNOW

CHALLENGES TO CHIMP RETIREMENT FOLLOWING THE FEDERAL COUNCIL OF COUNCILS Working Group report and a public comment period, the National Institutes of Health (NIH) announced last October a new standardized approach for retiring the remaining 180 chimpanzees it owns.

AAVS is pleased that NIH will play a greater role in assuring that government-owned and -supported chimpanzees are retired to Louisiana’s Chimp Haven in a more expedited and efficient manner. However, we are disappointed that, should a conflict arise regarding the evaluation of any chimpanzee’s suitability for transfer, a panel of NIH primate veterinarians will be the final decision-makers. These individuals likely have connections to the labs where the chimpanzees are kept, and their backgrounds working in primate research and testing laboratories present a strong possibility of bias.

AAVS has long been committed to ending the use of chimpanzees in laboratories. Each year, we support individual chimpanzees at Chimp Haven, along with building and habitat expansion to accommodate the increase in retired chimpanzees.

NIH received more than 4,000 comments on this issue in 2018 alone, so obviously the public cares about assuring that chimpanzees are allowed to live out their lives in a place designed for their care and comfort, not ease of use and accessibility for experiments. AAVS will continue to keep a watchful eye on this transfer process and keep pressure on NIH to not give in to efforts by animal research laboratories and lobbyists to thwart it.

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2019 CHEMICAL TESTING ON ANIMALS: DRIVING CHANGE

ARDF FUNDS MODELS TO REPLACE ANIMALS The Alternatives Research & Development Foundation (ARDF), an AAVS affiliate, has posted the 2018 Annual Open Grant Program recipients at www.ardf-online.org. The work being done by these recipients is especially impressive, and all five projects have great potential to make an impact in the biomedical research and testing fields, without the use of animals.

For example, three ARDF grant recipients are developing high-tech “biochips” of organs that mimic specific diseases. Dr. Hyun Jung Kim at the University of Texas is creating a “colitison-a-chip” to study irritable bowel disease in an effort to replace the use of mice, who are poor models of this ailment because they do not have gut bacteria similar to humans. At Binghamton University in New York, Dr. Gretchen Mahler and her team are developing a biochip to simulate the part of the kidney that filters blood, which could be used to replace animals in drug testing. A model of another filtering organ, the liver, is being created by Dr. Lawrence Vernetti at the University of Pittsburgh to study and treat diseases associated with blocked bile ducts.

Another project we’re excited about is a model of metastasized breast cancer that has spread to the bone, a condition that has low survival rates. Developed by Dr. Gargi Ghosh at the University of Michigan, this model could be used to screen novel drug treatments, a process that typically wastes thousands of animal lives. Additionally, Drs. Mariola Edelmann and Carlos Rinaldi at the University of Florida are studying cellular communication and its role in spreading disease throughout the body, using a cell’s own internal biomarkers instead of those manufactured in animals.

Since 1993, ARDF has provided more than $3.25 million in funding to research projects developing alternative methods that advance science and replace animal use in biomedical research, testing, and education.

China Slow to Go Cruelty-Free

MANY CRUELTY-FREE COMPANIES have shown great interest in selling their products in China. However, although it has since softened regulatory requirements, the Chinese government still uses animals to test the safety certain of cosmetic products. Because of this, the Leaping Bunny program will not certify companies selling in China and has revoked certifications from companies selling products there.

“Our cruelty-free standard is the most stringent of its kind, and our goal is to provide consumers with the most accurate

PHOTOS COURTESY OF CHIMP HAVEN (THIS PAGE) AND BY ISTOCK (OPPOSITE)

Sarah Anne (right), age 59, arrived at Chimp Haven in 2005 and is now good friends with Marie (left), age 28.

list of companies that don’t animal test,” explains Kim Paschen, Leaping Bunny’s Program Manager. “Listing companies that sell in China that claim they can avoid testing there compromises the integrity of the program and the Leaping Bunny logo.”

Although the Chinese government seems willing to support a cruelty-free market, challenges remain. Cosmetics Design Asia reported in October that “Although China has made significant strides moving away from animal testing…it may take more than five years” to completely stop using animals.

Hedy He, a regulatory analyst and editor of ChemLinked, pointed to a “lack of testing infrastructure and the technical capacity shortcomings of the industry” as being major obstacles.

However, “China has been investing heavily in new laboratories as well as training in non-animal testing,” noted Cosmetics Design Asia. The government is working with the Institute for In Vitro Sciences, a U.S. nonprofit research and testing lab that has trained Chinese scientists on how to use reconstructed skin cells for testing. Also, the China Working Group for the Validation of Alternative Methods has approved alternatives to measure photosensitivity and skin corrosion.

Japan, South Korea Stop Testing Pesticides on Dogs

LAST SEPTEMBER, South Korea announced that it will no longer use dogs in yearlong studies to test pesticides. Japan also made a similar announcement last year, following a study that found such tests provide little value in evaluating the safety of pesticides for humans, yet cause enormous animal suffering.

“This is very encouraging news,” said AAVS President Sue Leary. “Global acceptance of regulatory policies that help to reduce the use of animals in chemical testing shows a growing acceptance of nonanimal methods.”

During the controversial tests, dogs are fed food laced with a pesticide every day for one year, are then killed, and their organs examined to assess any health risks that may be associated with exposure to the chemical. The dog tests were part of a battery of testing that traditionally includes thousands of other animals, such as mice and rats, and causes extreme pain and suffering.

These regulatory changes were largely motivated by international pressure urging Japan and South Korea to join the U.S., European Union, Canada, India, and Brazil in ending the cruel tests. Humane Society International, which has worked on this issue for several years, reported that South Korea and Japan are believed to be the last major markets to end this cruel practice.

USDA NEEDS TO DO BETTER, SAYS ACCOUNTABILITY OFFICE

THE U.S. GOVERNMENT Accountability Office (GAO) released a report in 2018 concluding what many have already suspected: the U.S. Department of Agriculture (USDA) has not ensured that reported information from federal facilities using animals in research is provided to the public in “an accurate, clear, complete, and unbiased manner.”

Making this information (numbers of animals, types of animals, animal pain/ distress) available is an important part of the USDA’s oversight because it helps to maintain some level of transparency and accountability. However, the GAO found that although federal agencies followed reporting instructions provided by the National Institutes of Health, instructions provided by the USDA “have not ensured consistent and complete reporting in three areas: research with birds, [animal

use] outside the United States, and field studies.”

In 2000, our Alternatives Research & Development Foundation (ARDF) affiliate filed a lawsuit against the USDA for its failure to protect birds (as well as mice and rats) under the Animal Welfare Act (AWA). Although a subsequent amendment allows birds not bred for research to fall under the AWA regulations, the USDA still “instructs facilities to not report any birds in their annual reports, regardless of whether the birds are covered by the Act.” The GAO recommended development of a timeline for “defining birds that are not bred for research and that are covered by the [AWA], and…requiring that research facilities report …their use of birds covered by the Act.” But although the USDA stated that it would develop

such definitions by last September 30, it failed to do so. It also did not specifically respond to the recommendation about reporting bird numbers, and ARDF continues its efforts on this issue.

Also, regarding “activities that involve animal use outside the United States and…specific conditions under which field studies are or are not covered by the Act,” the GAO recommended that the USDA should instruct all federal facilities outside the U.S. to report their use of animals covered by the AWA. The agency disagreed, claiming that it is a “regulatory burden on federal facilities” and that “the absence of an exclusion does not…create any requirement to collect information.”

The USDA did agree to release a guidance document to clarify the definition of AWA-covered field studies in the near future.

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THE

GAMEforPLAN CHEMICAL TESTING

REFORM

By Martin Stephens

ADVOCATING ON BEHALF OF ANIMALS is usually a combination of playing offense and defense. Positive changes for animals should be proposed and supported (offense), whereas negative developments should be opposed (defense). Usually any single development (a bill, an agency action, a corporate program, etc.) falls into one camp or the other. For animals in laboratories, however, the situation is often more complicated. Such was the case with the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The bill, an update to the 1976 Toxic Substances Control Act (TSCA), aimed to give the Environmental Protection Agency (EPA) more authority to regulate potentially toxic chemicals in commerce, such as those used in pesticides.

Starting in 2005, the first efforts to reform TSCA raised the specter of a massive increase in animal testing, conducted by industry either in advance of registering new chemicals, or in response to requests by the EPA to support the safety of chemicals already on the market (so-called “existing chemicals”). In the end, the Lautenberg bill proved to be not only a vehicle for animal protectionists to limit such testing (defense), but also an opportunity to promote legislative provisions that encourage the development, evaluation, and implementation of non-animal methods and approaches (offense). The Lautenberg Act, now seen by most observers as a net positive for animals, became law in June 2016.

The following articles tell the story of how this legislative drama played out. William Bellamy and Paul Locke provide the context: the original impetus for Lautenberg bill, the major players, the legislative history, and more. Kristie Sullivan, Sara Amundson, and Catherine Willett provide the animal protection angle: what was at stake for laboratory animals, how the bill was modified to address animal concerns, and more. Some of the

developments they cover may sound familiar to AAVS members who received the organization’s alerts during those years. Joseph Manuppello and Jessica Sandler have analyzed the EPA’s actions in the days before and after passage of the Lautenberg Act and show how far the agency needs to go to embrace good science and alternative methods and approaches, in order to limit animal use. Finally, Catherine Willett discusses short- and longterm prospects for animal use not only under the new legislation, but also in light of wider developments among U.S. agencies with a stake in new testing approaches.

One way to understand the lobbying landscape of the Lautenberg Act is to think of a trio of sometimes competing, sometimes cooperating players: the chemical industry, environmental and public health organizations, and the animal protection community, with the EPA itself essentially on the lobbying sidelines. The industry (represented largely by its trade association, the American Chemistry Council) recognized that change was needed but didn’t want a new regulatory scheme that was too burdensome. The environmental organizations (e.g., Environmental Defense Fund) and their allies wanted more chemicals to be tested for toxicity. And the animal protectionists (e.g., Humane Society of the United States, People for the Ethical Treatment of Animals, Physicians Committee for Responsible Medicine) wanted the testing to employ alternative methods and approaches, not animals. As is usually the case, the outcome represented a compromise in which each side got some but not all of what it wanted.

The compromise with respect to laboratory animals is clear. In the short term, more chemicals will be tested, which is likely to mean some new animal testing, until alternative tests can cover the array of testing requirements. However, several provisions in the final bill should limit the extent of such testing, in favor of

ANIMAL TESTING, WHEN IT IS CONDUCTED, IS NOW INTENDED TO BE A LAST RESORT.

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EPA environmentalists chemical industry

less animal testing

public health advocates

more humane alternatives

animal protection groups

advancing alternative methods and approaches (“New Approach Methodologies”), as Sullivan, Amundson, and Willett explain.

Animal testing, when it is conducted, is now intended to be a last resort. And over the longer term, the agency is mandated to prepare a “Strategic Plan for Developing and Implementing Alternative Test Methods to Reduce Vertebrate Animal Testing,” which should expand the capabilities of alternative methods and increasingly narrow the scale of animal testing.

Indeed, the Lautenburg Act is seen as an important driver for implementing what has come to be called “21st century” toxicity testing, which emphasizes testing on human cells and tissues in vitro, as a means of improving safety assessments. Moreover, several federal agencies, singly and together, are developing roadmaps for replacing animal use in government-mandated testing.

To be sure, things may get worse before better under the Lautenberg Act, but overall, the future looks bright. According to Dr. Willett, “[d]epending on the level of commitment [by EPA and other agencies], it is possible that the use of animals for chemical safety assessment could be eliminated altogether within the next decade or so.”

Laws that focus squarely on animals in laboratories are enacted once in a generation, if that. Think of the Animal Welfare Act of 1966 and its subsequent amendments (which also addressed animals in other settings) and the ICCVAM Authorization Act of 2000. Yet the Lautenberg Act illustrates that other pieces of legislation provide opportunities to dramatically influence the situation for animals in animals. In the case of the TSCA reform, the efforts of animal protection organizations and their members forestalled any massive increases in animal testing, but also put into place a process that will advance alternative methods in future testing. Offense and defense paid off! AV Martin Stephens, Ph.D., is the Senior Research Associate for the Johns Hopkins Center for Alternatives to Animal Testing. He serves on the Editorial Board of www.AltTox.org and is a consultant for the Alternatives Research & Development Foundation.

What is the “Six-pack”?

It is shorthand for a series of animal tests traditionally required for determining a chemical’s toxic effects.

Acute Oral Toxicity To assess the general toxic effects on the body, rats are force-fed the chemical and observed for 14 days to note the dose that causes death and/or organ damage. Newer versions use fewer animals (e.g., 10 instead of 30) than the notorious LD-50 tests of the past.

Acute Dermal Toxicity This involves applying a chemical onto a shaved patch on the backs of at least six rabbits, rats, or guinea pigs (without anesthesia). The animals are observed for at least two weeks to determine the amount that causes death and/or organ damage.

Acute Inhalation Toxicity About 20 rats are put inside inhalation chambers to breathe chemical vapors for at least four hours. After about 14 days of observation, the vapor concentration that cause death and/or organ damage is noted.

(Primary) Eye Irritation Testing This updated version of the Draize eye test also involves restraining rabbits so that a chemical can be applied to one eye. The animals are observed for up to three weeks to determine the nature, extent, and reversibility of eye damage.

(Primary) Skin Irritation Testing During this test, a single chemical dose is put onto a shaved portion of about six rabbits’ backs, then removed after four hours. The animals are observed for two weeks to note skin damage.

Skin [Dermal] Sensitization To determine allergic responses to a chemical, a dose is applied to both ears of about a dozen mice. After being injected with a radioactive reagent on Day 6, the mice are killed so their lymph nodes can be examined.

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How We Got There: Reauthorizing the Toxic Substances Control Act IN 2016, CONGRESS PASSED the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The Act updated the Toxic Substances Control Act of 1976 (TSCA). This overhaul in our toxic chemicals law was a long time coming; in the 40 years between the passage of original TSCA and the Lautenberg Act, it became apparent that the way in which chemicals used in commerce were regulated was not working and needed a reboot.

Achieved at a time of intense political polarization around environmental issues, the passage of the Lautenberg Act marked a rare victory for bipartisanship, raising the question of how a broad range of actors came together to safeguard public health.

The original TSCA was supposed to give the Environmental Protection Agency (EPA) the ability to regulate chemicals already on the market (existing chemicals) and chemicals entering the market (new chemicals). The law required the EPA to create an inventory of existing chemicals and mandated that companies notify the agency at least 90 days before beginning production

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of a new chemical. With more than 60,000 chemicals already on the market at the time of TSCA’s passage and more than 20,000 added in following years, the inventory grew to include approximately 85,000 chemicals (Denison, 2017).

The 1976 TSCA law was well intentioned, but it soon became apparent that it was limited. It did not give the EPA the necessary authority to make determinations regarding the safety of these chemicals. One of the law’s major flaws was that it created a Catch-22 situation by requiring the EPA to have evidence of either risk posed by a chemical to human health or of widespread exposure to the chemical before requiring the company to carry out testing to evaluate the actual risk (Denison, 2017).

As a result, few existing chemicals were actually tested under the original law. According to 2015 testimony by James Jones, the former Assistant Administrator of the Office of Chemical Safety and Pollution Prevention, the EPA ultimately compelled testing of about 200 of the original 60,000 chemicals entered into the

PHOTO BY ISTOCK

By William Bellamy and Paul Locke

TSCA inventory (Jones, 2015). The agency struggled with the regulation of new chemicals, since TSCA did not set a minimum standard for data submitted as part of pre-manufacturing notices (PMN) to the agency. As a result, the majority of PMNs submitted prior to TSCA reform did not contain data regarding health effects of chemical exposure.

In addition to its limited ability to obtain data regarding chemical safety, the EPA also struggled with a requirement that it weigh the economic cost of regulation when determining whether or not to deem a chemical as presenting an unreasonable risk. The requirement forced the agency to demonstrate that the benefits of banning or regulating a chemical would exceed the costs, hamstringing its ability to take action.

Jones also noted that the EPA succeeded in implementing bans or regulations on only five of the original chemicals and suffered notable setbacks, such as a federal court striking down its attempt to phase out asbestos, a well-documented lung carcinogen (Jones, 2015). For new chemicals, the EPA took some form of regulatory action for less than 10 percent of the chemicals brought forward by companies between 1979 and 2004 (Wilson & Schwarzman, 2009).

Beyond assuming existing chemicals to be safe and allowing new chemicals into commerce with little or no safety data, the regulatory system under the original TSCA law suffered from several other structural flaws. The EPA could only require fees from industry in certain circumstances, and the fees went to the U.S. Treasury rather than the agency, leaving it with insufficient funding for safety assessments (Denison, 2017). Additionally, the law enabled companies to claim much of the data they provided to the EPA on their chemicals to be confidential business information, barred from being shared with local governments, first responders, and public health officials (Denison, 2017).

TSCA’s shortcomings led to heightened public and consumer concern, driving advocates and consumers at the state level and in the private sector to undertake their own efforts (Denison, 2017). From 2003 to 2010, state legislatures enacted 71 chemical safety laws targeting certain chemicals in consumer products, such as bisphenol A in baby bottles (Vogel & Roberts, 2011).

These actions, as well as chemical safety reforms in Europe and Canada, left the American chemical industry operating in an increasingly fragmented regulatory system both nationally and internationally.

Under the financial strain of balancing different regulatory requirements in different markets, the industry, led by one of its trade groups, the American Chemistry Council (ACC), ended its longtime opposition to TSCA reform. In 2009, the ACC released a document titled “10 Principles for Modernizing TSCA” in which it laid out a vision for regulatory reform from the perspective of industry (ACC, 2009). It called for a new version of TSCA designed to protect public health while preserving “America’s role as the world’s leading innovator and employer in the creation of safe and environmentally sound technologies and products of the business of chemistry” (ACC, 2009). The environmental advocacy community and the EPA also published principles for TSCA reform, and U.S. legislators

TSCA’S SHORTCOMINGS LED TO HEIGHTENED PUBLIC AND CONSUMER CONCERN. began to get more involved.

As support for TSCA reform grew, Senator Lautenberg introduced several bills, including the Safe Chemicals Act in 2010.

The Act proposed a higher safety standard and some limitations on the ability of industry to challenge the EPA judicially, but did not secure sufficient support to move forward (Krimsky, 2017). Senator Lautenberg continued to press for reform and introduced another iteration of the bill with Senator David Vitter of Louisiana in May 2013. Following the death of Senator Lautenberg, Senator Tom Udall of New Mexico signed on as a sponsor to help move TSCA reauthorization efforts. Ultimately, versions of the bill passed in the House and the Senate before Congress passed a reconciled version in June 2016. Shortly after the Lautenberg Act passed, President Barack Obama signed it into law. AV William Bellamy is a Research Assistant and Paul Locke, J.D., M.P.H., Dr.PH., is an Associate Professor in the Department of Environmental Health and Engineering at the Johns Hopkins Bloomberg School of Public Health. The opinions expressed in this article do not represent, and should not be construed to represent, the views of Johns Hopkins University or the Johns Hopkins Bloomberg School of Public Health.

American Chemistry Council. (2009). 10 Principles for Modernizing TSCA. Washington, DC: americanchemistry.com.

Denison, R. A. (2017). A primer on the new Toxic Substances Control Act (TSCA) and what led to it. Environmental Defense Fund.

Denison, R.A. (2009). Ten Essential Elements in TSCA Reform. 30 Environmental Law Reporter 10020 (January 2009) EPA. Essential Principles for Reform of Chemicals Management Legislation. Available at https:// www.epa.gov/assessing-and-managing-chemicals-under-tsca/essential-principles-reform-chemicalsmanagement-0.

Jones, J. (2015). Testimony of James Jones Assistant Administrator Office of Chemical Safety and Pollution Prevention U.S. Environmental Protection Agency Before the Committee on Energy and Commerce Committee Environment and The Economy Subcommittee United States Congress.

Krimsky, S. (2017). The unsteady state and inertia of chemical regulation under the U.S. Toxic Substances Control Act. PLoS Biology, 15(12), 1-10.

Schmidt, C. W. (2016). TSCA 2.0: A New Era in Chemical Risk Management. Environmental Health Perspectives, 124(10), 182-186.

United States General Accounting Office. (1994). Toxic Substances Control Act: Legislative Changes Could Make the Act More Effective.

Vogel, S. A., & Roberts, J. A. (2011). Why the Toxic Substances Control Act Needs an Overhaul, and How to Strengthen Oversight of Chemicals in The Interim. Health Affairs, 30(5), 898-905.

Wilson, M. P., & Schwarzman, M. R. (2009). Toward a New U.S. Chemicals Policy: Rebuilding the Foundation to Advance New Science, Green Chemistry, and Environmental Health.

Environmental Health Perspectives, 117(8), 1202-1209.

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Moving Chemical Testing Away from Animals

By Kristie Sullivan, Sara Amundson, and Catherine Willett

GROUPS COLLABORATED WITH OTHER NGOs AND INDUSTRY GROUPS TO DEVELOP JOINT ANIMAL PROTECTION PRINCIPLES. 8

2019 CHEMICAL TESTING ON ANIMALS: DRIVING CHANGE

Congress to include legislative language that would provide the impetus to bring about the vision of non-animal, 21st-century toxicity testing. Early on, we created a policy platform for TSCA reform that included: • Requiring the use of non-animal methods when available; • Providing funding and incentives for developing and using non-animal methods; • Containing flexible information requirements, rather than a fixed minimum data set; and • Requiring the EPA to pursue tiered testing strategies, screening methods, chemical grouping and read-across.

In 2008, an intensive lobbying campaign was launched to defeat various bills proposing TSCA revisions that would have vastly increased animal testing, in some cases requiring tests on more than 100 million animals. Groups collaborated with other NGOs and industry groups to develop joint animal protection principles, authored

PHOTOS BY ISTOCK

THE PUBLICATION OF THE NATIONAL Academy of Sciences report “Toxicity Testing in the 21st Century: A Vision and a Strategy” was a seminal moment in the push for alternatives to animals in testing. Here was one of the most respected scientific bodies in the nation recommending that we use human cells and tissues instead of animal tests, and that it would be better not only for the animals being killed in laboratories, but for human and environmental health too.

Since 2007, quite a bit of progress has been made on the scientific front—that is, creating and evaluating new non-animal methods that could be used to test chemicals. However, an overarching policy to ensure this vision came about was not in place.

But now, today, we do have a new law in place that marks the beginning of the end for animalbased toxicity testing. The Frank R. Lautenberg Chemical Safety for the 21st Century Act, which became law in June 2016, overhauled the Toxic Substances Control Act of 1976 (TSCA), which regulates industrial chemicals. Under the law, the Environmental Protection Agency (EPA) and chemical companies are now required to use available non-animal alternatives first before requiring or conducting animal tests. The EPA is also required to create a strategic plan to replace and reduce animal tests, provide incentives to use nonanimal alternatives, and report regularly to Congress on its progress.

Beginning in 2005, several bills were introduced to reform the TSCA. From the start, several animal protection groups, separately and together, lobbied

published articles, submitted testimony and testified to Congress on multiple occasions, held numerous meetings with Congressional staff, and launched a media campaign that included letters from the public and other elements.

From 2010 to 2013, there was some progress.

Language was introduced into draft bills Congress was considering that facilitated the use of nonanimal methods, strengthened tiered testing, and offered improvements in testing requirements, but stopped short of requiring the use of alternatives. In 2014, Senator Barbara Boxer (D-CA) introduced the first of several proposals to remove most of the animal protection language. The effort against animal protection interests persisted up to the conferencing of House and Senate bills in 2016, and continues today.

In 2015 and 2016, we found an ally in Senator Cory Booker (D-NJ), whose staff secured amendments in the Senate bill that included a requirement to preferentially use non-animal methods before animal tests. These provisions were supported by other senators as well, including Jim Inhofe (R-OK), Jeff Merkeley (D-OR), and Tom Udall (D-NM). This bill passed the Senate easily.

The House passed a companion bill that did not substantially address animal testing. A lengthy

and contentious conferencing process ensued to reconcile the two bills; it was vital to ensure that all essential language related to reduction and replacement of animal tests was included in the final bill. And it was! The final bill contained a section that requires the EPA to take steps to reduce and replace animal testing.

Today, several animal protection groups continue to provide input on the implementation of the law by providing technical comments to the EPA and by educating chemical companies about their responsibilities to use non-animal methods.

However, an ongoing danger is a lack of funding for the development of new non-animal methods.

Every year, the current administration has proposed massive cuts to the EPA budget in its annual budget proposal to Congress, but this funding is sorely needed.

In order to ensure that the promise of the National Academies report is realized, we have to be persistent. The good news is that we now have the letter of the law behind us. AV Kristie Sullivan, M.P.H., is the Vice President of Research Policy with the Physicians Committee for Responsible Medicine; Sara Amundson is President of the Humane Society Legislative Fund; and Catherine Willett, Ph.D., is Senior Director, Science and Regulatory Affairs, Humane Society International.

A Mandate for Change Hard-won provisions in the Frank R. Lautenberg Chemical Safety for the 21st Century Act specifically address the use of animals in chemical testing. Below is some of what is stated: (h) REDUCTION OF TESTING ON VERTEBRATES (1) In General — The Administrator shall reduce and replace, to the extent practicable, scientifically justified, and consistent with the policies of this title, the use of vertebrate animals in the testing of chemical substances or mixtures under this title by: (A) prior to making a request or adopting a requirement for testing using vertebrate animals, and in accordance with subsection (a)(3), taking into consideration, as appropriate and to the extent practicable and scientifically justified, reasonably available existing information, including: (i) toxicity information (ii) computational toxicology and bioinformatics (iii) high-throughput screening methods and the prediction models of those methods; and (B) encouraging and facilitating: (i) the use of scientifically valid test methods and strategies that reduce or replace the use of vertebrate animals while providing information of equivalent or better scientific quality and relevance that will support regulatory decisions under this title; (ii) the grouping of two or more chemical substances into scientifically appropriate categories in cases in which testing of a chemical substance would provide scientifically valid and useful information on other chemical substances in the category; and (iii) the formation of industry consortia to jointly conduct testing to avoid unnecessary duplication of tests, provided that such consortia make all information from such testing available to the Administrator.

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The Impact of the LCSA on Animal Use

by Joseph Manuppello and Jessica Sandler

W

hen the Lautenberg Chemical Safety Act (LCSA) finally passed in June 2016, after decades of work to modernize chemical testing in the U.S., advocates for animals breathed a huge sigh of relief. We knew there would still be obstacles ahead, but were hopeful that the tide was now turning on the Environmental Protection Agency’s (EPA) heavy reliance on animal tests. More than two years later, we are pleased to report that the agency has addressed many of our initial concerns and that at least some of the obstacles to minimizing animal use are being overcome.

In March 2017, we sifted through the information available on the EPA’s regulatory actions for new chemicals entering the market. To our dismay, we uncovered an extremely troubling fact: a dramatic increase in animal testing requirements was occurring under the new law. From June 2014 to June 2016, two years before reforms to the Toxic Substances Control Act, the EPA required or requested 30 animal tests for the hundreds of new chemicals it reviewed. However, from June 2016 to June 2018, the first two years after the LCSA was enacted, the EPA required or requested 524 animal tests for which the appallingly high number of 130,709 animals would be used.

Following the publication of our initial analysis,

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we met with top EPA officials and continued to press the agency to reduce these testing requirements in oral testimony at the agency’s public meetings, in written comments on its rulemaking and public notices, and in various other communications.

For example, we noted that one apparent cause for the increase was the agency’s failure to comply with the LCSA requirement to issue a “statement of need” each time the agency identified the need for the new information. This statement is supposed to explain the basis for any decision that requires the use of vertebrate animals. Instead, the EPA was using boilerplate text that in no way addressed the intent of this section, which is plainly to require the agency to explain why information that requires the use of animals is needed in each particular case.

Complying with this requirement, and with a modicum of effort, agency reviewers would likely have caught the cases we had found in which animal testing was required when approved nonanimal strategies exist. For example, the EPA required or requested 40 animal tests for skin sensitization even though a non-animal strategy was available. The EPA has since issued a draft interim policy on the use of alternative approaches for skin sensitization and has begun requesting that these alternative approaches be used to fill its information needs for this toxicological endpoint.

Another factor contributing to the increase in animal tests appeared to be the agency’s failure to

fully comply with the requirement to use tiered testing whenever new information is needed. That approach would use screening-level tests to inform the decision as to whether additional tests are necessary. For example, the EPA required a full prenatal developmental toxicity study, stating only that “information” indicated that the substance may cause liver or developmental toxicity in workers. It did not explain why this information justified a full study using 1,160 animals without first conducting screening-level testing. In fact, the agency identified only five tiered-testing strategies that it requested in 2017.

The EPA responded to these concerns with a series of policy changes that, for now at least, have largely eliminated specific testing requirements for new chemicals. Importantly, the EPA has modified language in its legal documents describing testing requirements to more generally describe the information that would help characterize human health and environmental effects associated with new chemicals—rather than list specific recommended tests— and to reflect a preference for tiered testing and the use of non-vertebrate testing strategies first. This encourages chemical companies to address the agency’s information needs through the use of non-animal test methods and strategies wherever possible. In addition, the EPA has committed to including the LCSA-mandated “statement of need” to explain the basis for any decision requiring the use of vertebrate animals.

Under the LCSA, the EPA must also prioritize and evaluate the tens of thousands of existing chemicals already on the market. In 2017, the agency proposed a frightening “pre-prioritization” scheme, which although not statutorily mandated, would have allowed it to require extensive animal testing for any or all of these chemicals. We continue to maintain that the current law provides the EPA no new authority to require testing for existing chemicals before it even begins to prioritize

them for risk evaluation.

Aside from this question of authority, the EPA’s current “working approach” for identifying potential candidates for prioritization would only flag existing chemicals for future testing when no in vivo, in vitro, or in silico data are available. In the near-term, the EPA will also primarily look to chemicals it already identified in 2014 for potential candidates, likely putting off extensive in vivo testing for the next few years. The EPA has affirmed its commitment to providing public notification if any of these chemicals are found to have insufficient information, and has opened dockets for each in order to gather available information voluntarily. In the event that the agency requires testing pre-prioritization, we are hopeful that this approach will minimize any new animal testing

The EPA has committed to including the LCSA-mandated “statement of need” to explain the basis for any decision requiring the use of vertebrate animals. requirements.

There is no question that the EPA has come a long way in the past few decades. When it unveiled a massive animal testing program in the late 1990s—which resulted in protests, Congressional hearings, and People for the Ethical Treatment of Animals’ negotiations with the White House to replace animal use—the EPA had not even considered animal protection organizations to be stakeholders, and certainly had not taken any animal protection issues into account when developing that plan.

Today, EPA officials are aware of both the scientific and ethical concerns associated with the use of animals in chemical testing, as witnessed by its strategic plan which actually sets eliminating animal use as its long-term goal. But because animals are still suffering and dying in chemical toxicity tests, there is still much to be done to ensure that good science prevails and that animal use in chemical testing is indeed eliminated. AV Joseph Manuppello is a Senior Research Analyst with the Physicians Committee for Responsible Medicine; Jessica Sandler, M.H.S., is Vice President for Regulatory Testing for People for the Ethical Treatment of Animals and head of the PETA International Science Consortium, Ltd.

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Where Can We Expect to Go from Here?

T

he updated Toxic Substances Control Act’s (TSCA) inclusion of the first-of-its-kind mandate to try all else before resorting to animal testing was a huge success for animals in the U.S.; however, the way forward is likely to be bumpy.

It’s pretty clear that in the short term, there will be an increase in the use of animals due to the Environmental Protection Agency’s (EPA) increased authority to ask for information about both new and existing chemicals. We’ve already seen this in 2017 and 2018, and it will likely carry through for several more years. As time goes on and the EPA develops and begins to implement its Strategic Plan for Developing and Implementing Alternative Test Methods to Reduce Vertebrate Animal Testing, there should be a progressive decrease in the use of animals. Depending on the level of commitment, it is possible that the use of animals for chemical safety assessment could be eliminated altogether within the next decade or so.

The Strategic Plan describes a process for developing and implementing New Approach Methodologies (NAMs) that reduce vertebrate animal testing; however, some animal testing is likely to be included, usually as a last or confirmatory step. As non-animal approaches continue

to develop, animal testing as a component of NAMs will progressively decrease.

For NAMs to succeed, it will be extremely important (and is legally required) to ensure that they are reliable and provide “information that is of equivalent or better scientific quality and relevance” for the decision at hand. NAMs already exist that are more scientifically fit for some TSCA purposes. For example, using available data from high-throughput non-animal tests (e.g. from the EPA’s ToxCast program)1 and relatively straightforward prediction of exposure, it possible to carry out a risk-based prioritization of chemicals.2 This type of approach would be quite useful for the requirement to prioritize existing chemicals under the revised TSCA for further assessment.

Furthermore, using these kinds of methods, it is possible to determine not only which chemicals potentially pose the greatest risk relative to others, but also to see which aspect (hazard or exposure) contributes the most to any uncertainty, and therefore what additional information would best reduce that uncertainty.

Regulators can also begin to test combinations of chemicals to better understand the effects of exposure to many things at once, as happens in real life. Since there are so many possible combinations, it’s

IT IS POSSIBLE THAT THE USE OF ANIMALS FOR CHEMICAL SAFETY ASSESSMENT COULD BE ELIMINATED ALTOGETHER WITHIN THE NEXT DECADE OR SO. 12

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currently not possible to look at these issues using animal tests; it would require more animals than can be bred, more laboratories than exist, and hundreds if not thousands of years.

Another example of NAMs that provide better scientific information is those recently developed to predict a chemical’s likelihood of causing skin allergy.

Several have been shown to do a better job of predicting human outcomes than the standard animal tests, based on known human responses to a long list of chemicals.3 It won’t always be possible to compare the NAMs to human data, since there is (thankfully!) little information about how most chemicals affect humans with respect to things like cancer and birth defects. However, previous data from animal experiments in the past can demonstrate a range of variability, providing good benchmarks. In the few reviews of animal data that have been done so far, the NAMs that have been evaluated to measure the same activity perform at least as well.4 There are currently only a relatively small number of NAMs that have undergone evaluation for use in chemical safety assessment. Future reduction of animal use requires the development of newer methodologies to cover more aspects of biology. Critical for this development is better understanding of the underlying biology. After decades of intensive research, much is known about mostly non-human biology, which is of limited use for predicting human results, but which can be built upon to better understand human biology.

Several groups of scientists—some collaborating with their international colleagues—are collecting biological information that is currently in journal articles

PHOTO BY ISTOCK

By Catherine Willett

New Approach Methodologies (NAMs) show promise for reducing and eliminating animal tests.

and different databases around the world, evaluating this information for reliability and organizing it in computer programs that describe the biological processes (or pathways or networks) that occur in cells, tissues, and organs. This will help scientists design NAMs that can more comprehensively and accurately assess potential chemical activities, and address biological issues that scientists are having trouble with or have no current way of addressing (e.g., effects on the endocrine system).

These collaborative databases must continue to grow, with as many people as possible, including researchers and regulatory and industry scientists contributing their specialized knowledge to make these databases progressively more useful. The Humane Society of the United States, through its Human Toxicology Project, supports one such project, the Adverse Outcome Pathway (AOP) framework.

The AOP project is coordinated by the Organization of Economic Cooperation and Development and is supported by its 36 member countries. The most active participants are the U.S. EPA and the European Commission, but there is global participation that we are committed to increasing.

The prospect for successful implementation of the EPA’s Strategic Plan is supported by several recently published roadmaps by U.S. agencies and institutes that aim to reduce the use of animals, including the NICEATM Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States, the Food and Drug Administration’s Predictive Toxicology Roadmap, and the recently announced Strategic and Operational Plan for Continued Leadership from the U.S. Federal Tox21 Program. Although the roadmaps are addressing the use of NAMs in different contexts, common themes emerge, including the importance of “the 3Cs:” communication, collaboration, and a serious commitment throughout the organization(s). Recently there has been a rise in all three Cs among U.S. regulatory agencies as well as within the National Institutes of Health. The 3Cs are also increasing internationally, with significant investment by the European Commission in funding for alternative methods, and in greater acceptance of these methods globally.

Although animal use under the new TSCA is likely to rise temporarily, it will

be up to stakeholders such as animal welfare groups and the public to monitor the EPA’s activities, hold the agency accountable, and insure timely implementation of newly developed NAMs. In the longer term, the commitment demonstrated in the EPA’s Strategic Plan and the growing momentum for development and adoption of newer methods, combined with the increasing corroboration that these methods are indeed better and more health-protective, portends both a safer and more humane future. AV Catherine Willett, Ph.D., is Senior Director, Science and Regulatory Affairs, Humane Society International.

1. https://www.epa.gov/chemical-research/toxicity-forecasting 2. Wambaugh et al. (2013). High-throughput models for exposure-based chemical prioritization in the ExpoCast project.

Environmental Science & Technology. 2013 Aug 6;47(15):847988. doi: 10.1021/es400482g.

3. Kleinstreuer et al. (2018) Non-animal methods to predict skin sensitization (II): an assessment of defined approaches, Critical Reviews in Toxicology, 48:5, 359-374, DOI: 10.1080/10408444.2018.1429386.

4. N. Kleinstreuer, Acute Systemic Toxicity Implementation Plan, presentation at the ICCVAM public meeting May 24, 2018: https://ntp.niehs.nih.gov/iccvam/meetings/iccvam-forum2018/03a-atimplementation.pdf

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INTERVIEW

New Jersey Senator Cory Booker (far left) was instrumental in helping to pass animal testing reform legislation initiated by his predecessor, the late Senator Frank Lautenberg.

Cory Booker served as the mayor of Newark, New Jersey, for seven years before being elected to the U.S. Senate in 2013, following the death of Senator Frank Lautenberg. In 2016, Senator Booker enlisted bipartisan support among his colleagues to help pass the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which updated the Toxic Substances Control Act (TSCA) and requires the Environmental Protection Agency (EPA) to use more non-animal testing methods. We asked Senator Booker about his commitment to the issue and to animals.

AAVS: What prompted your involvement with this legislation?

SEN. BOOKER: TSCA was originally approved by Congress in 1976, and was meant to protect the public and the environment from dangerous chemicals. Unfortunately, the law never worked as it was intended to. My predecessor, Senator Frank Lautenberg, spent years fighting to make improvements to TSCA, and stakeholders from the environmental community and from the chemical industry all

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PHOTO COURTESY OF OFFICE OF SENATOR CORY BOOKER

Senator Cory Booker

agreed that action was needed. As a member of the Senate Environment and Public Works Committee, I saw an opportunity to work with my colleagues on both sides of the aisle to update this law to make it stronger and more protective of the most vulnerable members of our society, including children. At the same time, I quickly recognized that a more functional TSCA could lead to an exponential increase in cruel, often unnecessary, animal testing if safeguards were not put in place in the new legislation.

What have you learned about non-animal testing methods and their role in science?

I have learned that non-animal testing methods— things like high-speed computer modeling and in vitro studies using cells—can now very often provide information that is more scientifically reliable and better able to predict human and environmental health outcomes than outdated animal tests can.

You gave credit to Senator Lautenberg’s widow, Bonnie, for her role in getting the bill passed, but how did you secure support among your colleagues for the animal testing amendments?

I would like to again thank Bonnie Lautenberg for her tireless efforts pushing members of Congress to support this chemical safety reform legislation. Once my colleagues sat down with my staff and me, and we were able to show them the latest science and how alternative test methods and strategies were now very often superior to animal tests, they agreed that animal testing should only be used when there was no alternative, and that we should be pushing the Environmental Protec-

tion Agency to move away from animal testing as quickly as possible.

How do you see this legislation improving consumer safety?

This legislation gives the EPA the clear authority to evaluate and restrict or ban dangerous chemicals, for both chemicals already in use as well as for new chemicals that are being developed. If the EPA was to faithfully implement the law, the public would have far greater protections than they have had in the past from toxic chemicals. Unfortunately, the [current administration’s] EPA has promulgated regulations that allow [it] to ignore known uses and exposures from hazardous chemicals, resulting in increased risks to vulnerable populations such as workers and children. Congress and the courts need to require that the EPA do better.

We’ve heard the stories about you rescuing dogs when you were mayor of Newark. Have you always had a special relationship with animals?

With each year that goes by I realize more and more the urgent need to expand my compassion to include all of God’s creatures. This has led me to become vegan, and inspires me to work on animal welfare bills in the Senate.

What advice do you have for animal advocates who want to get involved in the political process?

Do it! Follow your passion and find a way to get involved, whether working for an advocacy group or for an elected official, or by running for office yourself. To create the change we want to see in the world, we all need to be engaged—democracy is not a spectator sport! AV

“WE SHOULD BE PUSHING THE ENVIRONMENTAL PROTECTION AGENCY TO MOVE AWAY FROM ANIMAL TESTING AS QUICKLY AS POSSIBLE.” In accordance with our IRS classification as a 501(c)(3) organization, AAVS cannot and does not endorse or oppose candidates for elective office.Therefore, this interview, which was conducted in 2018, should not be taken as such.

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Giving

TRIBUTES HONORING LOVED ONES

SUPPORT THE AAVS MISSION

WITH THE GENEROUS SUPPORT of members like you, AAVS has furthered the development of non-animal, alternative research models and testing methods for more than 35 years. We are proud to have contributed to an early replacement for the dreaded Draize eye test in 1981.

To fortify our commitment to reducing and replacing animal use by science and industry, AAVS established the Alternatives Research & Development Foundation (ARDF) in 1994.

ARDF funds cutting-edge creations, including virtual organs, 3D models, computer simulations, sophisticated cell and tissue cultures, and other technologically advanced tools. Modern alternatives yield more accurate data, providing a greater benefit to humans, while also sparing hundreds of thousands of animals from needless suffering and death. This is the future of science: creating new and better ways to conduct research, without animals as the test subjects.

Progressive thinkers can effect ARDF grant recipient Dr. Lena Smirnova (left) positive change. By attracting and AAVS/ARDF President Sue Leary at last year’s meeting of the Society of Toxicology. innovative scientists at leading universities to engage in work on alternative methods, ARDF achieves progress in scientific and biomedical research without harming animals.

Your support of our mission helps to advance humane science and reward researchers who are reshaping the future to end the unnecessary suffering of animals.

With your help, AAVS and ARDF are able to effectively fund, develop, and promote non-animal methods in areas where animal models are currently the norm.

Please consider making a special gift today to support the development and promotion of alternatives. You may designate your gift using the enclosed envelope, or donate securely online at www. aavs.org/Alternatives. Thank you for joining this movement for humane science that helps animals instead of hurting them.

For information on planned giving, leadership gifts, recurring gifts, or other support, contact Chris Derer, Director of Development & Member Services, at 800-SAY-AAVS or cderer@aavs.org. When including AAVS in your estate plans or sending a donation, please use our legal title and office address: American Anti-Vivisection Society, 801 Old York Road, Suite 204, Jenkintown, PA 19046-1611. EIN: 23-0341990. AAVS is a not-forprofit 501(c)(3) organization to which contributions are 100 percent tax-deductible under federal and state law.

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In memory of Shasta I, Shasta II, and Dane. We miss you so much—you were such a joy! Though you have traveled from us, we are so glad you are together.

See you in Heaven. Love, Mom and Dad. Marian and Carl Patey Manassas, VA In loving memory of our bestest cat, Pickle. He was the sort of cat that gave love when you needed it, not just when it fit into his schedule! We now know that our other two cats don’t like each other; Pickle just kept “the boys” together…

The Nicola Family Shorewood, WI In memory of Joseph R. Maisuk. To my father, who taught me to be good to animals. I miss you more every day.

Sherri Maisuk Duluth, MN In memory of Nona Jamila Nieves, our beloved Doxie and “daughter.” For over 16 years you blessed our lives with so much love and happiness. Mommy and Daddy will always love you; our heart, our joy, our world. Until we meet again, keep safe the pieces of our heart you took with you.

Irene Nieves Sebastian, FL In memory of my sweet Cindy and (notso-sweet) Raina, two street kitties who became beloved members of our family.

Veronica Ferguson Niagara Falls, NY In memory of Rex Alexander: father, humanitarian, WWII veteran, and cat lover.

Matthew Alexander Lowell, MA In honor of Vicky and Keith.

Judith Rasmussen New Milford, CT

In memory of Terry Fistel.

Denise Partyka Manahawkin, NJ In honor of my sister, Janice Kramer— a truly generous and devoted animal advocate.

Denise Kennedy West Chicago, IL In memory of all animals.

Katherine Klevenow Shaker Heights, OH In memory of Caroline Earle Wright.

We’re a family of animal caregivers, and proud of CEW. Joan Earle Condoret Pittsboro, NC In memory of Jerry the dog.

Irwin Berkman New York, NY In honor of Sue Leary, AAVS President.

Brava to you, Sue! And as always, in memory of past president, William Cave; he and AAVS brought me into the antivivisection struggle.

Richard Abbott Santa Paula, CA In memory of Tina Nelson. Always in my heart.

Susan Giglia Damariscotta, ME In memory of Rosemarie Hess Allen, a loving, wonderful friend to people and animals.

Lynn Jenkins Pennsauken, NJ In memory of Rosemarie Hess Allen: gentle soul, loving friend, and lover of animals.

Trisch Van Sciver Albuquerque, NM

In memory of my beloved cousin, Rosemarie Hess Allen. Mimi, as she was affectionately called, was a kind and beautiful soul, and her love of animals ran deep and true. She will be sorely missed.

Joan Olson Wyomissing, PA In memory of Roger Boxill.

Paula Krauss Brooklyn, NY In memory of Robert R. Logan.

Gerald Pollack Old Greenwich, CT In memory of Oreo, my cat. Thank you for 16 years of love, support, and companionship. I miss you desperately.

Gloria Fleming Las Vegas, NV In honor of all of my best friends.

Donna Pynchbek Kilmarnock, VA In memory of Baby Girl. My sweet, loving, fun soul-mate kitty; 17 years of happy she brought to my life. Miss you every day!! Love, Mom. Patti Rich Grand Junction, CO In memory of Cleo, who spent the first half of her life as a puppy mill breeding dog, locked in a tiny cage. Always in our hearts.

Joyce Sherman Harleysville, PA In memory of Elizabeth A. DeTine, a truly kind and generous woman.

Judy and Martin Shore Denver, CO In honor of all animals. Stay free!

Paula Knickerbocker Boise, ID

In memory of Ulysses, the most loving and beautiful Maine Coon cat ever. You are always in our hearts.

Louise and Gerard Feulner Maywood, NJ In memory of my best friend, June Riley.

Ginger Crowder Pine Bluff, AR In memory of Lauren R. Sweeney.

Joan Baca Granger, IN In honor of my son, Kevin McGuire.

Dora McGuire Deal, NJ In honor of my man Wilson.

Darlene McFarland Gardnerville, NV In memory of our kitty, Cher, who is very missed.

Drs. Gwendolynn and John Newman De Pere, WI In memory of Bert.

Babette Eddington Schamburg, IL In memory of my rabbits Sparkie, Bun, and Chip. I will love you always.

Florence Friebel Upper Gwynedd, PA In memory of Mario Riccio. To my loving father who was a brave hero of WWII and rescued a war dog named Jughead.

Dawn Estey Oyster Bay, NY In memory of Thomasina, our dear, beautiful calico cat who shared our lives for 19 years! You looked right into my eyes, and rest in our patio forever!

Nancy Wolcott Bowling Green, OH

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TRIBUTES continued

In memory of Muyal. Wherever you are now, God bless you! Thank you for coming into our lives!

Kirubakaran Periyannan Santa Clara, CA In memory of our sweet girl Shea‌ we miss her every day.

Maurine and George Lembesis Pleasant Valley, NY In memory of Lucky Kepic. We will never forget you!

Eleanor Swiderski Olyphant, PA In memory of Jezzabelle.

Constance Brown Berkley Bethesda, MD In memory of Charles Samec, a very compassionate man who loved animals.

Carolyn Samec Carol Stream, IL In memory of Pauline Johnson. Her love and loyalty to animals lives on through her daughter.

Susan Foster Fort Myers, FL In honor of Patricia Duncan.

Susan H. Dudley Glen Rock, PA In memory of Lisa LeFort.

Christopher Radlinski Plymouth, MN In honor of Aggie.

Roberta Elkins Sacramento, CA

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In memory of Lisa LeFort. Lisa was a young, brilliant and talented person who cared about the rights and treatment all living things: human and animal. Wish I would have known her better. She leaves behind an equally talented and caring husband whom we are honored to call friend.

Audrey Britton Plymouth, MN

In memory of James Katz, beloved son.

Richard and Lynn Katz Marblehead, MA

In memory of my mom, Karen Geoffrey Ennis, who cared deeply about all living beings and gave to many animal charities until her death at age 64.

Rachel Stern San Rafael, CA

In memory of Pansy and Annabelle; two sweet, loving, gentle cats.

Susan Sheridan Rancho Palos Verdes, CA

In memory of Margaret Donovan, an animal lover and a shelter worker.

James and Diana Davies Shirley, NY In memory of Rodney.

Hilde Basch New York, NY In memory of Lucy B. After years of neglect and abuse that crippled your body and faith in men, we found you and started recovery. We enjoyed you for the last, happiest years of life. You will always be in our hearts.

Hilary Black Colrain, MA In memory of Dusty, a beautiful and precious soul. Gone too young, but never, ever forgotten.

Mary Luckey Sevierville, TN In memory of the Hipster, for 16 years the best friend a girl could have. After three years, I still look for you in your favorite spots and miss our nightly walks.

Eve Hadjinian Cypress, CA

2019 CHEMICAL TESTING ON ANIMALS: DRIVING CHANGE

In memory of Louis Schurman. Dad, in memory of your 88th birthday: June 3, 2018. Miss you, and thinking of you today and always. God bless you.

Robert Schurman Paramus, New Jersey

In memory of my Siamese cat Blackboots—I love you! You deserve Heaven more than I do.

Clark Skinner Tulsa, OK In memory of my boy, Pepe, and my girl, Bella, two of my cats that passed away this past year.

Beth Taddonio Old Saybrook, CT In memory of Shadow, a fantastic companion and friend.

Barry Mueller APO, AE In memory of Joseph Maisuk. I miss you, daddy! Love you!

Sherri Maisuk Duluth, MN In memory of Boswell Kriss. You are forever my unicorn, firmly occupying a corner of my heart.

Lorna Kriss Sausalito, CA In honor of Buddy and Molly, nine-yearold beagle siblings whom I rescued.

Marcia Bennett Fletcher, NC

PHOTO BY ISTOCK

In memory of Dorothy Desmond. She loved animals and hated injustice of any kind. I am sorry she died too young.

Virginia Dominguez Champaign, IL

In memory of the little ones who suffer and die every day in laboratories all over the world.

Unseen but not forgotten In memory of Gladys Palm, who sustained the local Humane Society through lifelong volunteer service.

Edmond O’Melia Lake Lillian, MN In honor of Janice Kramer. Love to the best sister ever and a very generous animal supporter.

Denise Kennedy West Chicago, IL In memory of past AAVS President, William Cave.

Richard Abbott Santa Paula, CA In memory of Carol Onstad, a loving, caring and compassionate human being. The Earth and its inhabitants will miss her, especially all the children she taught at Fairchild Tropical Botanic Garden.

Paul and Coky Michel Miami, FL In memory of my dear cats, Jackie and Arthur; my rabbit, Honey Bunny; and my dog, Princey.

Michaele Bober New York, NY In memory of Petunia. You were the best cat ever. You are missed.

Kathleen Heller Signal Hills, CA In honor of the staff of AAVS. Thank you for a job well done!

Jamie Kovacs Burks Osceola, IN In memory of Teddy, the best ginger cat who gave us all he had and never asked for much in return. Always in our hearts forever.

Karen LoGrasso Bohemia, NY

In memory of Casper, the most wonderful cat in my world.

Leah Conyers Cool, CA In memory of Leonard, Eunice, and Carol McComb.

Lawrence McComb Rehoboth Beach, DE In honor of my son.

Carolyn Casser Milwaukee, WI In memory of Lucky LuLu Belle.

James Spates Austin, TX In memory of Scott M. Dull and Rex L. Dull.

Julie Dull South San Francisco, CA In memory of Daisy Jones, Julie and Dave’s sweet and loving dog.

Susan Peay San Antonio, TX In memory of Phoenix, beloved feline companion of 20 years.

Heather Fuller Nottingham, MD

In memory of Margaret Dawson. Her motto was simple: be kind, be fair, exert yourself to be your very best. We carry her in our heart and our action, two loving daughters.

Alisa Spector and Meg Spera Gig Harbor, WA In memory of our deceased pets.

Louise and Gerard Feulner Maywood, NJ In memory of my beloved cat, Midnight.

Laura Nalls Perryman, MD

You can honor or memorialize a companion animal or animal lover by making a donation in his or her name. Gifts of any amount are greatly appreciated. A tribute accompanied by a gift of $50 or more will be published in AV Magazine. At your request, we will also notify the family of the individual you have remembered. All donations are used to continue AAVS’s mission of ending the use of animals in biomedical research, product testing, and education.

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Members’ Corner WHAT’S UP, DOC?

For the animals,

Chris Derer Director of Development & Member Services

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PHOTO COURTESY OF MARIA BERARDO

THROUGHOUT HISTORY, RABBITS have occupied many positions on the relationship spectrum with humans, from pop figure to food source. Domestic bunnies can be wonderful family members, while their wild cousins are frequently treated as agricultural pests.

Rabbits’ lives are challenged by predators and climate change in the wild, while their tame disposition has unfortunately made them vulnerable for use as test subjects in laboratory research.

The European domestic species’ Latin name, Oryctolagus cuniculus, translated as “digger of tunnels,” stems from the rabbits’ frequent habitation in warrens, a series of connected underground burrows. Often wrongly identified as rodents, rabbits are properly classified as lagomorphs. They may be found on every continent except Antarctica, in environmental conditions ranging from desert to tundra, and from sea level to mountain tops. Rabbits are herbivores, but also consume their own droppings for nutrition.

Domestic rabbits who are purpose-bred for use in labs generally don’t get to enjoy “retirement,” although some are released to rescues and may then be adopted. Rabbits are adorable, gentle, intelligent, curious, sociable, and beautiful. A bunny could be the perfect buddy for you! They can also help humans as therapy animals.

Our perception of bunnies is often colored by mythology and misunderstanding; various cultures have associated rabbits with fertility, It is perfectly fitting that Maria Berardo, who works with AAVS’s Leaping innocence, rebirth, good luck, bad luck, mischief, and intoxication.

Bunny Program, is a rabbit guardian. Maria has a longtime affinity for rabbits, and has cared for many furry friends, including Theodore, a In several Asian cultures, rabbits are depicted as moon deities—lunar seven-year-old Holland Lop rescue. Theodore loves making forts out of boxes, and enjoys watching prime-time television, including “Jeopardy.” residents who make sticky rice cake treats. Dating back as far as 600 B.C., a rabbit’s foot has served as a good luck charm (unless you’re the rabbit), while just uttering “rabbit” is bad luck on a boat, according to sailor superstition.

Rabbits are well represented in popular culture, with characters that include the Easter Bunny, Peter Rabbit, Bugs Bunny, the Velveteen Rabbit, Thumper, Roger Rabbit, Miffy, the Energizer Bunny, Br’er Rabbit, Harvey the White Rabbit, Oswald, and the Killer Rabbit of Caerbannog.

Given their reputation for prolific breeding, it is morbidly ironic that rabbits were once regularly killed as part of a test to determine human pregnancy. Developed in 1931, that bioassay remained in use for decades (with later refinements that spared rabbits’ lives) until the progression of technology produced simple, in vitro test devices.

Indeed, technology is the key to ending animal testing and sparing the lives of millions of rabbits and other species. The development of alternative research methods is paving a path to a future for humane science that benefits both animals and humans. So, alternatives are what’s up, doc.

BE A PART OF THE SOLUTION Animal testing is a problem–for animals and for people–because we need human-relevant biomedical research and testing to advance human health.

Please help ARDF achieve our mission to fund and promote scientifically rigorous, non-animal alternative methods in research, testing, and education. With your investment in alternatives research, we will help change science and make it better for everyone.

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“It is simply not possible with all the animals in the world to go through chemicals in the blind way we have at the present time, and reach credible conclusions about the hazards to human health.� Joshua Lederberg, Ph.D., 1958 Nobel laureate