FDA would allow marketing of food from genetically engineered animals
Genetically engineered animals and their products, most notably food products, are closer to reaching the market now that the Food and Drug Administration has released draft guidance on their regulation.
The FDA intends for the guidance document, which the agency released Sept. 18 for comment, to clarify its regulatory authority and the requirements and recommendations for developers of GE animals and products from GE animals.
The AVMA responded with a statement noting potential benefits of GE animals in endeavors such as research and food production. The AVMA policy on “Creation and Use of Genetically Modified Animals” supports creation of genetically modified animals as long as they do not harm the environment, and the health and well-being of the animals remain preferential to human values and needs.
In the FDA guidance, which focuses primarily on food animals, the agency defines genetically engineered animals as those containing a recombinant DNA construct to give them new traits. The FDA Center for Veterinary Medicine has worked with developers of GE animals to ensure that food from these animals does not enter the food supply until or unless the FDA authorizes such use.
The FDA plans to regulate heritable rDNA constructs as new animal drugs under the Federal Food, Drug, and Cosmetic Act. Developers of GE food animals would need to demonstrate that the rDNA construct is safe and effective in the GE animal, that food from the GE animal is safe for human consumption, and that the GE animal does not pose environmental risks.
To complement the FDA guidance on GE animals, the Department of Agriculture also is seeking input on actions and approaches to consider under the Animal Health Protection Act.
The FDA document and the USDA request for information appeared in the Sept. 19 Federal Register, online at www.gpoaccess.gov/fr/browse.html. More information is available by visiting www.fda.gov/cvm/GEAnimals.htm or contacting Larisa Rudenko, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855; phone, (240) 276-8247; email@example.com.
Submit comments regarding the FDA draft guidance until Nov. 18 by mail to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852; or electronically by searching for FDA-2008-D-0394 at www.regulations.gov. Submit comments relevant to the USDA request for information until Nov. 18 by mailing two copies to Docket No. APHIS-2006-0188, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-1238; or by searching for APHIS-2006-0188 at www.regulations.gov.
From the AVMA
AVMA seeks nominations for euthanasia panel working groups
Nominations and expressions of interest are sought for membership in working groups that will contribute to the next edition of the AVMA Guidelines on Euthanasia. The current guidelines are posted at www.avma.org/issues/animal_welfare/euthanasia.pdf.
Members selected for working groups will have demonstrable expertise in particular euthanasia techniques or the application of those techniques to various animal types, species, or uses.
Working groups for which nominations are sought are inhalant agents, noninhalant agents, physical agents, equine, food animals (large animals, poultry), zoo/wildlife (including reptiles and amphibians), birds, aquatics (fish, marine mammals), companion animals (dogs, cats, birds, small mammals, reptiles, amphibians), laboratory animals (rodent, nonrodent, primate), and depopulation.
Expressions of interest and nominations are also sought for an ethicist, who will engage with the working groups to provide that perspective.
Letters of interest or nomination, together with the individual's curriculum vitae—including a current list of publications—should be e-mailed to firstname.lastname@example.org; faxed to (847) 925-1329; or surface mailed to Kathy Sikora, Animal Welfare Division, AVMA, 1931 North Meacham Rd, Suite 100, Schaumburg, IL 60173.
Closing date for submissions is Dec. 31. Questions regarding the panel or this process may be directed to the AVMA Animal Welfare Division at (847) 925-8070, Ext. 6635.
AVMA working for you
The AVMA is working to get equal pay for veterinarians who perform nearly identical government jobs as physicians, who are often paid more; to develop new funding sources for researchers; and to raise public awareness about veterinarians' contributions to animal and human health.
To read “10 reasons to be a member of the AVMA,” go to www.avma.org, follow the link labeled “JAVMA News,” and use the pull-down menu for the Nov. 1 issue.
Nominations to AVMA entities being accepted
One of the strengths of the AVMA is the extent to which its members can influence the direction of the organization. By serving on councils, committees, and other AVMA entities, volunteer leaders have an opportunity to weigh in on a broad range of veterinary-related issues, from animal welfare and food safety to education and animal drugs and vaccines.
Dr. W. Ron DeHaven, AVMA CEO and executive vice president, first got a sense of the AVMA's broad range of activities as an official with the Department of Agriculture serving on an Association committee. “It was through my experience with the Animal Welfare Committee that I first understood and became energized about what AVMA is doing for veterinary medicine,” he said.
Nominations are invited for 78 vacancies on Association entities and 11 liaison positions.
The House of Delegates will fill council openings when it meets in July 2009 in Seattle. Council nomination materials, including descriptions of the councils, and instructions for publishing candidates' biographies in the 2009 Campaign Guide, are posted on the AVMA Web site, www.avma.org/about_avma/governance/volunteering. These materials can also be obtained by calling AVMA headquarters at (800) 248-2862, Ext. 6605, or e-mailing OfficeEVP@avma.org. Council nominations must be submitted by April 1, 2009, to the AVMA Office of the Executive Vice President. Nominations for the Council on Education, however, must be submitted by Feb2,2009.
The AVMA trust and committee vacancy positions are to be filled by the Executive Board at its April 2009 meeting. Nominations are also invited for the Political Action Committee Policy Board member to be appointed by the House Advisory Committee at its March 2009 meeting.
Trust and committee nomination materials, including descriptions of the various entities, are also posted on the AVMA Web site. Inquiries on these vacancies can be answered at (800) 248-2862, Ext. 6605, or by e-mail at OfficeEVP@avma.org. Trust, committee, and PAC nominations should be submitted to the AVMA Office of the Executive Vice President no later than March 2, 2009.
NCI funds $10.9 million for retrovirus models of cancer
A team of researchers from The Ohio State University's Comprehensive Cancer Center and the College of Veterinary Medicine have received a $10.9 million, five-year grant from the National Cancer Institute to further their studies of retrovirus-associated cancer.
The principal investigator is Dr. Michael Lairmore, professor and chair of the Department of Veterinary Biosciences. Dr. Lairmore is also associate director for basic research at the cancer center and a member of the center's Viral Oncogenesis Program.
The new grant follows a five-year, $8.9 million NCI grant received in 2003 for studies investigating how some retroviruses cause lymphocytes to proliferate, leading to cancer.
The study comprises five interactive projects and three cores. Besides Dr. Lairmore, project or core leaders are Patrick Green, PhD; Kathleen Boris-Lawrie, PhD; Thomas Rosol, DVM, PhD; Lawrence Mathes, PhD; and Stefan Niewiesk, DVM, PhD.
“Each laboratory has interrelated goals to define critical biological events that control the alteration of lymphocytes,” Dr. Lairmore said. “These findings will help us further discover therapeutic targets against retroviral-induced lymphoma and its lethal side effects syndromes, such as hypercalcemia.”
California law strengthens protections for researchers
California lawmakers have strengthened protections for academic researchers who have lately come under increasing attacks by animal rights extremists. Passage of the Researcher Protection Act follows a rash of violence, threats, and harassment targeting University of California scientists and their families.
Governor Arnold Schwarzenegger signed the measure into law Sept. 28. The legislation is intended to enhance law enforcement's ability to protect academic researchers and their families from acts of violence and intimidation by anti-animal research extremists. The law took effect immediately.
Assemblyman Gene Mullin introduced the Researcher Protection Act (AB 2296) in February at the behest of the University of California. It received strong bipartisan support and passed the Assembly and the Senate in August by unanimous votes.
“Increasingly, the potential for innovative thought and new medical therapies is jeopardized by threats aimed at researchers and their families,” Mullin said. “The signing of AB 2296 sends a message that California recognizes its researchers and their families need to be protected from threats of violence.”
On Aug. 2, two University of California-Santa Cruz scientists were targeted in firebomb attacks. Both targets do health-related research on animals. Earlier, the home of a UC-Los Angles researcher was vandalized by animal rights extremists who left a note threatening to burn the house down. A burning effigy was also left on the doorstep of another researcher's home.
What AB 2296 did was to make it a misdemeanor offense to publish information describing or depicting academic researchers, their immediate families, or their locations with the intent that another person use the information to commit a crime involving violence or a threat of violence.
In addition, AB 2296 makes entry onto the residential property of an academic researcher for the purpose of “chilling,” preventing the exercise of, or interfering with, the researcher's ability to carry out their academic work a misdemeanor.
Research in Progress
Genomics breeding program to benefit poultry industry
A breeding program using an entire animal genome is beginning under the direction of Purdue University scientists and two of the largest international poultry breeding companies.
Purdue animal sciences professor William M. Muir, PhD, is co-director for the research project to determine the viability of using whole genome DNA selection to improve the accuracy and efficiency of breeding methods. This strategy is called whole genome selection.
The project will test a novel way to select poultry for traits that are difficult or costly to measure or are not highly hereditary. Traits of interest include bone density, productivity, animal well-being, feed efficiency, yield, egg quality, growth, robustness, and disease resistance.
Dr. Muir is partnering with Hans H. Cheng, PhD, of the U.S. Department of Agriculture and the poultry breeding companies Hendrix Genetics in the Netherlands and Cobb-Vantress Inc. of Siloam Springs, Ark.
The USDA's $2.5 million research funding is being matched by the companies, which are also supplying additional resources, making the funding exceed $10 million.
Nominations open for world leadership award
The University of Pennsylvania School of Veterinary Medicine has announced a deadline of Dec. 1 for nominations for its World Leadership in Animal Health Award.
The unrestricted award of $100,000 is given annually to a veterinarian who has dramatically changed the practice and image of the profession and substantially influenced the lives and careers of others. Nominations are considered on the basis of merit alone. To be eligible, candidates must hold a degree in veterinary medicine from a school listed in the AVMA Membership Directory & Resource Manual.
The 2008 Penn Vet World Leadership Award recipient was Dr. Bernard Vallat, director general of the World Organization for Animal Health. Because of Dr. Vallat's leadership, the organization now stresses the importance of sharing scientific information across international boundaries and promotes veterinary services as well as a continued commitment to food safety and animal welfare. By clearly linking human and animal health, Dr. Vallat emphasized the positive impact of animal health policies on poverty reduction and public health.
Nominators may share their intentions with the candidate. For nomination instructions, go to www.vet.upenn.edu/PennVet/News/WorldAwards/tabid/859/Default.aspx and click on the link under Nominees.
The Veterinary Community
Purdue names two veterinarians as great teachers
Purdue University has added Drs. Robert “Pete” L. Bill and John F. Van Vleet to the university's Book of Great Teachers. They are among only nine professors from Purdue's School of Veterinary Medicine on the list of 316 teachers.
Dr. Bill is the director of Purdue's Veterinary Technology Program. He also served on the AVMA Committee on Veterinary Technician Education and Activities from 1999-2005. Dr. Van Vleet is the associate dean for academic affairs at the Purdue veterinary school. He also is a professor of veterinary pathology.
25 years: Wisconsin veterinary school celebrates anniversary
The University of Wisconsin-Madison School of Veterinary Medicine celebrated its 25th anniversary this year. The school is not only the youngest on campus, established in 1983, but also is the second-youngest veterinary school in the nation.
Wisconsin confers approximately 80 DVM degrees each year. Annually, more than 20,000 cases are referred to the school's veterinary teaching hospital with board-certified veterinarians in 18 specialties.
At the same time, the school's faculty continues to work on a wide variety of projects that embody the one-health concept. For example, they have:
• improved organ storage solution so transplant organs can be kept alive longer
• developed total joint replacement surgery techniques that enhance long-term success
• researched vaccines, leading to revision of national pet vaccination standards (avoiding overvaccination of pets)
Ongoing work addresses infectious diseases, cancer, spinal cord injury and restoration of breathing, ophthalmology, and food safety, emphasizing on-farm food safety.
To thank donors and in celebration of its anniversary, the school dedicated its Walk of Honor entryway to the teaching hospital Sept. 11. The dedication featured the unveiling of a new sculpture commissioned from Alexa King, the same local artist who was chosen to create the Barbaro memorial sculpture that will be placed at the famed racehorse's burial site at Churchill Downs in Kentucky.