On November 2nd, 2006, the Center

celebrated its first quarter century with

an anniversary symposium held at

the Johns Hopkins Bloomberg School

of Public Health. The event, titled “A Celebration of

Progress in Humane Science,” brought together more

than 160 participants from around the world—in-

cluding researchers in both academia and industry,

policymakers, regulators, animal welfare advocates,

students, and members of the concerned public. The

symposium featured lectures and discussions about

the past, present, and future of the alternatives com-

munity, and highlighted the CAAT’s groundbreak-

ing role in supporting the “Three Rs” of alternatives:

Reduction, Refinement, and Replacement. The event

also honored the pioneering director of the Center,

Alan Goldberg, for his 25 years of dedicated service.

The symposium lectures, a video documentary about

CAAT’s 25 years, and a gallery of photos are available

on the CAAT Web site.

CAAT Celebrates 25 Years of Humane Science

Newsletter • Spring 2007Update on the work of the Johns Hopkins Center for Alternatives to Animal Testing

Johns Hopkins Center for Alternatives to Animal Testing (CAAT)111 Market Place, Suite 840Baltimore, MD 21202-6709, USATel: (+1) 410-223-1692Fax: (+1) 410-223-1603http://caat.jhsph.edu

CAAT is an academic center within the Johns Hopkins Bloomberg School of Public Health. The Johns Hopkins University and CAAT are 501(c)(3) organizations.

Remembering Bill RussellWilliam Moy Statten Russell, one of the scientists who first formulated the 3Rs of alternatives, died July 27, 2006. He was 81.

CAAT released a short video honoring Bill Russell at the 25th Anniversary Symposium. The video, which includes Russell’s famous Gilbert and Sullivan-inspired singing lecture, is available on the CAAT site under “Media Center.”

New laws, regulations, and programs, such as the EU’s 7th Amendment to the Cosmetic Directive, REACH, and the California Safe Cosmetics Act, demand that toxicologists produce more information using fewer

animals, and in many cases, obtain hazard information using no animals at all.

These fast-approaching global regulatory deadlines make CAAT and its work more important than ever. In anticipation of these new requirements, we have been working closely with the CAAT Advisory Board, creating an “Industry Strategy Workgroup,” to better understand and articulate the significant economic impact these regulatory changes will have on the US cosmetics and personal care, petrochemical, and crop protection industries. The Workgroup realizes the compelling demand for the design and development of new in vitro methodologies based on human cell cultures and the need to accelerate the development of alterna-tives as the only cost-effective way to meet industry’s needs.

The potential economic impact of non-compliance with the 7th Amendment to the Cosmetic Directive is clear. Any company that does not use non-animal testing within the outlined time-frame will risk losing its European market share. And while the 7th Amendment and REACH appear contradictory, the reality is that it would be impossible to comply with REACH (given that 30,000 chemicals require attention in year one alone) using current toxicological testing methods. The economic impact of REACH will be substantial and far-reaching unless alternative methodologies are developed. If industry continues to use existing animal testing methods to meet the requirements, compliance will cost billions of dollars—and millions of animals.

To remain competitive in the global marketplace, US industries must become leaders in humane science and the development and deployment of alternatives. CAAT is positioned to work with those companies that seek to respond to social and regulatory pressures and to advance toxicology by championing replace-ment alternatives. Working together, CAAT and industry can accelerate the development, validation, and use of scientifically-based replacement methods in toxicological testing. CAAT has set these immediate goals:

Develop and implement strategic plans for US industry to respond to REACH and the 7th Amendment

Assist in implementing an evidence-based approach to validation

Work with industry to develop a “harmonized approach” to alternatives

Assist companies in protecting their market share

For more information on participation in this important CAAT/Industry alliance, please contact Betsy Nessen Merrill at (410) 223-1614 or bmerrill@jhsph.edu.

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Global Regulatory Changes

The California Safe Cosmetics Act requires manufacturers of cos-metics and personal care products to report the use of potentially hazardous ingredients to the state Department of Health Services (DHS). The California DHS maintains a public list of these products and ingredients, and it has the authority to investigate products for toxicity under normal use and to require manufacturers to submit health effects data. It is widely anticipated that legislation similar to the California law will be introduced on a Federal level in the US in 2007.

In the post 7th Amendment and REACH world, traditional toxi-cological testing methods can no longer keep up with the new demands for testing chemicals and personal care products. The need to develop alternative testing methods is clear—and the European Union is leading the way. The European Partnership for Alternative Approaches to Animal Testing (EPAA), launched at the November 5, 2005 “Europe goes Alternative” meeting, addresses both the social concerns and regulatory requirements in REACH and the 7th Amendment to the Cosmetic Directive.

The EPAA was created to promote the development of modern alternative approaches to safety and product testing, based on the “3Rs”—replacement, reduction and refinement. The EPAA rep-resents an unprecedented collaboration between the European Commission, major companies, and trade federations from seven industry sectors. Participants are committed to accelerating the development, validation, and acceptance of alternative approaches over a five-year period.

CAAT Director Alan Goldberg participated in both the EPAA’s “Europe Goes Alternative” meeting and the first Annual Report meeting, held in December, 2006 in Brussels. It was decided that the Partnership’s primary focus and actions should be to:

Map past and current 3Rs activities in order to plan and priori-tize future actions

Prioritize, promote, and implement future research based on the application of the 3Rs

Identify, disseminate, and implement best practices in the use of the 3Rs

Implement the 3Rs in the regulatory and decision-making processes

Promote validation and acceptance based on the 3Rs

Dr. Goldberg believes a similar approach is necessary in the United States, and that CAAT can initiate this process. “It is important to understand that the EPAA has significant corporate support for two reasons: government has stepped in and provided both the structure and staffing for the EPAA, and these European corpo-rations understand the immediacy of the regulatory changes brought on by REACH and the 7th Amendment. Corporate America must begin to focus on developing alternative methods in toxicological testing, or run the risk of losing market share.”

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Europe Embraces the 3RS

As California Goes. . . .

But What About Validation?That’s the number one question in the world of toxicological testing. In the face of REACH, the 7th Amendment to the Cosmetic Directive, and the California Safe Cosmetics Act, validation becomes the priority for the corporate and regulatory communities.

When REACH becomes a reality in June, industry will be required to provide data on 30,000 chemicals—in the first year alone. Many acknowledge the prohibitive costs (in money, time, and animal lives) associated with traditional testing methods. The need for alternatives is clear. Currently, however, the process for toxicological validation is inefficient and yields very few fully accepted methods.

CAAT’s faculty and staff have been listening to our industry part-ners and focusing our efforts to find answers. Dr. Thomas Hartung of ECVAM introduced the concept of Evidence-Based Toxicology at CAAT’s 25th Anniversary Symposium. As a result of Dr. Hartung’s talk, Dr. Ellen Silbergeld, Professor of Environmental Health Sciences at Hopkins’ School of Public Health, began developing a concept for evidence-based toxicology modeled on the “Cochrane Collaboration” of evidence-based medicine, and presented this concept to the CAAT Advisory Board. Together, CAAT and ECVAM will continue to advance an evidence-based approach to toxicological testing, developing “best practices” for validated responses.

The Cochrane Collaboration’s primary purpose is to provide valid and accepted consensus information on clinical trials and methodologies. Cochrane’s evidence-based medicine provides effective, valid meth-odologies, and its results are accepted by both the NIH and AMA. It is a Web-based model in which Interest Work Groups work with a Steering Committee within the scientific community. Once a consensus state-ment is posted on the Collaboration website, interested community members can create work groups to design a study. The recommenda-tions of the work groups are posted, reviewed, and updated by other community members. Studies and data are integrated to reach a conclusion rather than a hypothesis. Because the process is evidence-based, with all studies adhering to specific guidelines and criteria, it has had great success in the medical world.

CAAT is working with Dr. Silbergeld (a CAAT Faculty member) to design an evidence-based toxicology model for the alternatives community. As regulatory deadlines approach, this has become a priority for CAAT. Without a vehicle for validation and acceptance, the new regulatory requirements will create a crisis in toxicological testing. Though still in the planning phase, CAAT’s program envisions strategically placed Cochrane-type centers around the world, bringing communities together through Web-based communications. We are fortunate that the Johns Hopkins School of Public Health is home to an established Cochrane Collaboration Center for medicine. The Center’s Director has offered assistance developing this model for toxicology, and the exist-ing center provides a structure that can be immediately emulated.

The alternatives community has the resources to successfully produce a Cochrane model. Based on its past successes in bringing together diverse stakeholders, CAAT can provide the structure for industry and academia to work in concert. Should industry and academia be able to present conclusions in tandem to the regulatory community, ap-proval, validation, and acceptance of alternative methodologies will become a reality in the near future.

Test martSDNTDevelopmental Neurotoxicity2

Developmental neurotoxicity (DNT) is a major issue in children’s health worldwide. The developing human nervous system is susceptible to many toxicants, and chemical exposure during development may cause lasting neurological deficits.

CAAT’s first TestSmart DNT meeting, held March 2006, sought to identify the concerns relating to the science and policy of DNT and to developing alternative testing methodologies. DNT II will assess progress made in developing DNT alternatives, reassess the priori-ties and recommendations established at DNT I, and outline new and continuing goals.

This meeting will bring together diverse stake-holders from around the globe, including research scientists, government scientists, regulators, policy analysts, industry representatives, academ-ics, and advocacy groups concerned with children’s health, animal welfare, and environmental protection.

For more information about DNT testing, and to read the report from the first TestSmart DNT meeting, please visit: http://caat.jhsph.edu/pro-grams/workshops/testsmart

Save the Date: November 12-14, 2008

CAAT Associates Program—You Asked, We ListenedThis June, we are launching an exciting new initiative—the CAAT Associates Program. For $15,000 per year, CAAT Associates will attend an annual meeting and update session which will provide them with the latest information on CAAT’s research, EU activities and regulations, the US regulatory system, and other pertinent topics. Associates also will receive reports highlighting important issues in global toxicity and product safety testing and corresponding laws and regulations. The CAAT Associates Program is a cost-effective way to show you CAAT’s value—a value that will pay huge dividends for you and your company in the future. For more information or to become a CAAT Associate, please contact Betsy Nessen Merrill at 410-223-1614 or bmerrill@jhsph.edu

6th WORLD CONGRESS IN TOKYO

CAAT MULTIMEDIA

Register now for the 6th World Congress on Alternatives and Animal Use in the Life Sciences, which will meet August 21-25, 2007. This marks the first time the World Congress has convened in Asia. For more information and to register, visit http://www.ech.co.jp/wc6.

The CAAT website, http://caat.jhsph.edu, was rebuilt from the ground up in 2006. One of the exciting new additions is the CAAT Media Center, which features a growing collection of multimedia content.

Visit the CAAT Media Center today and watch the late Bill Russell perform his Gilbert and Sullivan-inspired “lecture” in song on the 3Rs. Or watch the 3-part documentary about CAAT’s history: “25 Years of Humane Science,” which premiered at the 25th anniversary symposium.

More content is being added regularly—stay tuned!

One of the ways CAAT promotes the “R” of refinement is through our Animal Welfare Enhancement (AWE) Awards. The focus of these awards is to improve housing, handling, and/or experimental situations for laboratory animals. These relatively small grants are intended for those who actually work hands-on with the animals, such as laboratory and animal technicians.

These awards have an impact well beyond the recipients them-selves. AWE winners consistently note that colleagues and co-workers become interested in their refinement efforts and in the positive impact on the research and on the animals in their care.

AWE winners have spread the word to broader audiences as well. For the past three years, several awardees have presented their findings at the annual PRIM&R (Public Responsibility in Medicine and Research) conference designed for those involved with Institutional Animal Care and Use Committees (IACUCs).

CAAT launched the AWE program in 2004 and has granted 26 of the awards to date. For more information, see: http://caat.jhsph.edu/programs/awards/AWE

Spreading the Word About Refinement

THE BEST POLICYCAAT believes that education is the best policy. And now, thanks to a $1.5 million, five-year grant from an anonymous donor, we are developing a new program in public policy, education, and outreach. The program is aimed at educating policy-makers and legislators about the need for alternatives to the use of animals in toxicity and safety testing and in biomedical research.

For more information, see the CAAT website: http://caat.jhsph.edu

CROs: READY TO GO IN VITRO?CAAT is interested in developing a one-day seminar for Contract Research Organizations that will highlight the latest techniques and discuss both academic and commercial methodologies. This would be a learning experience aimed at helping you develop marketable in vitro products. If you would be interested in taking part in such a seminar, please contact us at rsharma@jhsph.edu.

For more than a quarter century, CAAT’s research grants program has provided critical seed money for scientists interested in developing alternative methods. To date, the Center has funded more than 300 grants for a total of more than $6 million. The most recent grants have focused on the areas of developmental toxicol-ogy, neurotoxicology, immunotoxicology, and refinement.

The nine grants awarded in the 2007-2008 cycle include studies aimed at:

evaluating the use of zebrafish as an alternative model (replacing rodents) for screening chemicals for adverse effects on the developing nervous system

developing a quick, easy, and more cost-effective in vitro method to evaluate large number of chemicals for their potential to cause allergic contact dermatitis

using neural stem cells for in vitro models to investigate the toxicological effects of drugs and environmental agents on the nervous system

determining the most effective analgesic to allow for smooth-er, shorter post-surgery recovery in rabbits.

For abstracts of these grants and others, and for more information about the CAAT grants program, please visit: http://caat.jhsph.edu/programs/grants/

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CAAT Grantees Work to Replace and Refine Animal Testing

CAAT OFFERS CERTIFICATE IN HUMANE SCIENCEIn conjunction with the Policy Program, CAAT has initiated a Certificate in Humane Sciences Program. This program, offered through the

Bloomberg School of Public Health, will be open to persons holding undergraduate or graduate degrees in public health or the biomedical sciences. It also will be made available to others through a variety of mechanisms, including Hopkins “open courseware,” workshops, lecture series, and other outreach activities.

In establishing this certificate and related educational efforts, CAAT will work actively with federal regulatory departments and agencies, such as the FDA, the EPA, and the USDA. Program courses will be offered not only at Hopkins’ East Baltimore campus, but also at the Hopkins Montgomery County campus (located only a few miles from the headquarters of these government agencies

and departments), and on the Web. Our offerings of courses and lectures will be readily available to regulators, scientists, researchers, and animal care professionals at these agencies and departments.

IN BRIEF. . .

CAAT MULTIMEDIA

CROs: READY TO GO IN VITRO?

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Charitable Giving to Support the Johns HopkinsCenter for Alternatives to Animal Testing

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Favorable treatment of capital gains if the asset given is in the form of securities or real estate that have appreciated in value.

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Michelle L. Glennon, Esq., Sr. Gift Planning Advisor Johns Hopkins Institutions Wyman Park Building, 7 South 3400 N. Charles Street Baltimore, Maryland 21218 Phone: 410-516-7954 or 800-548-1268 mglennon@jhu.edu

Betsy Nessen Merrill Director of Development and Communications The Center for Alternatives to Animal Testing Johns Hopkins Bloomberg School of Public Health 111 Market Place / Suite 840 Baltimore, MD 21202-6709 Tel: (410) 223-1614 bmerrill@jhsph.edu

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